Arogya Compliance
Regulatory Approvals
Select the regulatory approval you require to grow your business. Explore industry-wise licences and registrations for medical devices and related health businesses.
Industry
MedTech
EnquireBusinesses engaged in the import, manufacture, sale and distribution of medical devices, including their software, components, accessories and other articles intended for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury.
End-to-end assistance for obtaining an Import Licence (Form MD-15) for medical devices, including their software, spare parts, components and accessories.
End-to-end assistance for obtaining a Registration Certificate for manufacturers and importers of class A non-sterile and non-measuring medical devices.
End-to-end assistance for obtaining a Manufacturing Licence (Form MD-5/MD-9) for medical devices, including their software, spare parts, components and accessories.
End-to-end support for obtaining a Sale Licence (Form MD-42) for the sale, stock or exhibition of medical devices.
End-to-end support in obtaining LMPC registration for manufacturers of pre-packaged medical devices under the Legal Metrology framework.
End-to-end regulatory assistance for obtaining LMPC registration for importers of pre-packaged medical devices under the Legal Metrology framework.
End-to-end support in securing trademark registration and protecting brands associated with medical devices and healthcare products.
End-to-end support in obtaining a Market Standing Certificate for medical devices from the relevant Central or State licensing authority.
End-to-end assistance for obtaining a Non-Conviction Certificate from the relevant Central or State licensing authority.
Comprehensive review of medical device labels to assess compliance with applicable labelling requirements.
Comprehensive review of product claims, promotional materials and advertisements to assess compliance with applicable laws.
End-to-end legal and regulatory assistance for registration on the Integrated Pharmaceutical Database Management System (IPDMS) portal.
End-to-end legal and regulatory assistance for submission of price lists in Form VI under the Drugs (Prices Control) Order, 2013.
End-to-end legal and regulatory assistance for filing price fixation applications in Form I before the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for filing price revision applications in Form II before the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for submitting discontinuation intimations in Form IV to the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for preparing and filing quarterly returns in Form III with the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for obtaining Department of Pharmaceuticals approval for foreign advanced clinical training programmes.
End-to-end legal and regulatory assistance for preparing and submitting marketing expenditure disclosures and self-declarations under the Uniform Code for Marketing Practices in Medical Devices.
End-to-end legal and regulatory assistance for obtaining approvals for foreign advanced clinical training of healthcare professionals under the UCMPMD framework.
End-to-end support for obtaining a BIS licence for domestically manufactured medical devices and related products.
End-to-end assistance for obtaining a BIS licence for foreign manufacturers supplying regulated products to the Indian market.
End-to-end support for obtaining BIS registration under the Compulsory Registration Scheme (CRS) for notified electronic and electrical products.
Industry
Pharmaceuticals
EnquireBusinesses engaged in the import, manufacture, sale and distribution of drugs, including medicines, biological products and pharmaceutical formulations intended for use in the diagnosis, treatment, mitigation or prevention of disease.
End-to-end assistance for obtaining an Import Licence (Form 10) for drugs intended for import into India.
End-to-end assistance for obtaining a Manufacturing Licence (Form 25) for the manufacture of drugs for sale or distribution.
End-to-end assistance for obtaining regulatory approval to manufacture or import a new drug in India.
End-to-end assistance for obtaining LMPC registration for manufacturers of pre-packaged pharmaceutical products.
End-to-end assistance for obtaining LMPC registration for importers of pre-packaged pharmaceutical products.
End-to-end assistance in securing trademark registration and protecting pharmaceutical brands.
Comprehensive review of pharmaceutical labels to assess compliance with applicable labelling requirements.
Comprehensive review of product claims, promotional materials and advertisements to assess compliance with applicable laws.
End-to-end assistance for registration on the Integrated Pharmaceutical Database Management System (IPDMS) portal.
End-to-end assistance for preparing and submitting price lists in Form V under the Drugs (Prices Control) Order, 2013.
End-to-end assistance for filing price fixation applications in Form I before the National Pharmaceutical Pricing Authority.
End-to-end assistance for filing price revision applications in Form II before the National Pharmaceutical Pricing Authority.
End-to-end assistance for submitting discontinuation intimations in Form IV to the National Pharmaceutical Pricing Authority.
End-to-end assistance for preparing and filing quarterly returns in Form III with the National Pharmaceutical Pricing Authority.
End-to-end assistance for preparing and submitting marketing expenditure disclosures and self-declarations under the Uniform Code for Pharmaceutical Marketing Practices (UCPMP).
Industry
BioTech
EnquireBusinesses engaged in the research, development, manufacture and commercialization of biotechnology products, including biologics, recombinant products, cell and gene therapies, and other biotechnology-based innovations.
End-to-end assistance for obtaining an Import Licence for medical devices, including in-vitro diagnostic kits, biosensors, and other biological-origin devices classified as medical devices.
End-to-end assistance for obtaining a Registration Certificate for manufacturers and importers of class A non-sterile and non-measuring medical devices.
End-to-end assistance for obtaining a Manufacturing Licence (Form MD-5/MD-9) for medical devices, including their software, spare parts, components and accessories.
End-to-end support for obtaining a Sale Licence (Form MD-42) for the sale, stock or exhibition of medical devices.
End-to-end support in obtaining LMPC registration for manufacturers of pre-packaged medical devices under the Legal Metrology framework.
End-to-end regulatory assistance for obtaining LMPC registration for importers of pre-packaged medical devices under the Legal Metrology framework.
End-to-end support in securing trademark registration and protecting brands associated with medical devices and healthcare products.
End-to-end support in obtaining a Market Standing Certificate for medical devices from the relevant Central or State licensing authority.
End-to-end assistance for obtaining approvals from the Review Committee on Genetic Manipulation (RCGM) for research, contained use and trials involving genetically engineered organisms and products.
End-to-end assistance for obtaining an Import Export Code (IEC) for biotechnology-related import and export activities.
End-to-end legal and regulatory assistance for obtaining approvals to conduct clinical trials for biological products, biosimilars and biotechnology-derived products, where applicable.
End-to-end assistance for establishing and registering an Institutional Biosafety Committee (IBSC) for research involving recombinant DNA technology and genetically engineered organisms.
End-to-end assistance for obtaining approvals or registrations from the National Biodiversity Authority under the Biological Diversity Act, 2002, where applicable.
End-to-end assistance for obtaining approvals from the Genetic Engineering Appraisal Committee (GEAC) for activities involving genetically engineered organisms and products, where applicable.
End-to-end assistance for obtaining recognition of in-house Research and Development (R&D) units from the Department of Scientific and Industrial Research (DSIR).
Comprehensive review of medical device labels to assess compliance with applicable labelling requirements.
Comprehensive review of product claims, promotional materials and advertisements to assess compliance with applicable laws.
End-to-end legal and regulatory assistance for registration on the Integrated Pharmaceutical Database Management System (IPDMS) portal.
End-to-end legal and regulatory assistance for submission of price lists in Form VI under the Drugs (Prices Control) Order, 2013.
End-to-end legal and regulatory assistance for filing price fixation applications in Form I before the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for filing price revision applications in Form II before the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for submitting discontinuation intimations in Form IV to the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for preparing and filing quarterly returns in Form III with the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for obtaining Department of Pharmaceuticals approval for foreign advanced clinical training programmes.
End-to-end legal and regulatory assistance for preparing and submitting marketing expenditure disclosures and self-declarations under the Uniform Code for Marketing Practices in Medical Devices.
End-to-end legal and regulatory assistance for obtaining approvals for foreign advanced clinical training of healthcare professionals under the UCMPMD framework.
End-to-end support for obtaining a BIS licence for domestically manufactured medical devices and related products.
End-to-end assistance for obtaining a BIS licence for foreign manufacturers supplying regulated products to the Indian market.
End-to-end support for obtaining BIS registration under the Compulsory Registration Scheme (CRS) for notified electronic and electrical products.
Industry
Cosmetics
EnquireBusinesses engaged in the import, manufacture, sale and distribution of cosmetics intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering appearance of the human body.
End-to-end assistance for obtaining an Import Registration Certificate (COS-2) for cosmetics intended for import into India.
End-to-end assistance for obtaining an Import Registration Number (COS-4A) for cosmetics already approved for import into India.
End-to-end assistance for obtaining permission to import a new cosmetic into India under Form COS-3.
End-to-end assistance for obtaining a Manufacturing Licence (COS-8) for the manufacture of cosmetics for sale or distribution.
End-to-end assistance for obtaining permission to manufacture a new cosmetic in India under Form COS-3.
End-to-end assistance for obtaining a Loan Licence (COS-9) for the manufacture of cosmetics at a licensed manufacturing facility.
End-to-end assistance for preparing and submitting the self-certificate of compliance with Good Manufacturing Practices (GMP) under Form COS-7.
End-to-end assistance for obtaining a BIS Licence for domestically manufactured cosmetic products, where applicable.
End-to-end assistance for obtaining a BIS Licence for foreign manufacturers supplying regulated cosmetic products to the Indian market, where applicable.
End-to-end assistance for obtaining BIS Registration under the Compulsory Registration Scheme (CRS) for notified products.
End-to-end assistance for obtaining LMPC Registration for manufacturers of pre-packaged cosmetic products.
End-to-end assistance for obtaining LMPC Registration for importers of pre-packaged cosmetic products.
End-to-end assistance for securing trademark registration and protecting brands associated with cosmetic products.
Comprehensive review of cosmetic labels to assess compliance with applicable labelling requirements.
Comprehensive review of product claims, promotional materials and advertisements to assess compliance with applicable laws.
Industry
Food & Beverages (F&B)
EnquireBusinesses engaged in the manufacture, processing, import, storage, distribution and sale of food and beverages intended for human consumption.
End-to-end assistance for obtaining FSSAI Registration for eligible food business operators under the Food Safety and Standards Act, 2006, including through the Tatkal registration mechanism, where applicable.
End-to-end assistance for obtaining an FSSAI State Licence for food business operators engaged in the manufacture, processing, storage, distribution or sale of food products, including through the Tatkal licensing mechanism, where applicable.
End-to-end assistance for obtaining an FSSAI Central Licence for eligible food business operators, including importers, exporters and businesses falling under the jurisdiction of the Central Licensing Authority, including through the Tatkal licensing mechanism, where applicable.
End-to-end assistance for obtaining modifications to an existing FSSAI licence or registration, including changes in products, business activities, premises or other particulars.
End-to-end assistance for obtaining approval for non-specified food and food ingredients under the applicable Food Safety and Standards Regulations.
End-to-end assistance for obtaining regulatory clearance for imported food consignments through the FSSAI Food Import Clearance System (FICS).
End-to-end assistance for preparing and filing Annual Returns under the Food Safety and Standards (Licensing and Registration of Food Businesses) Regulations.
Comprehensive review of labels of food products to assess compliance with applicable food labelling requirements.
Comprehensive review of product claims, nutrition claims, health claims, advertisements and promotional materials to assess compliance with applicable food laws.
End-to-end assistance for securing trademark registration and protecting brands associated with food and beverage products.
End-to-end assistance for obtaining LMPC Registration for manufacturers of pre-packaged food products.
End-to-end assistance for obtaining LMPC Registration for importers of pre-packaged food products.
End-to-end assistance for obtaining regulatory approvals for genetically modified food products from the competent authorities, where applicable.
End-to-end assistance for obtaining a BIS Licence for domestically manufactured food products covered under applicable Quality Control Orders (QCOs).
End-to-end assistance for obtaining a BIS Licence under the Foreign Manufacturers Certification Scheme (FMCS) for notified food products intended for the Indian market.
Industry
In Vitro Diagnostics
EnquireBusinesses engaged in the import, manufacture, sale and distribution of in vitro diagnostic medical devices, including reagents, calibrators, controls, kits, instruments, software and specimen receptacles intended for examination of specimens derived from the human body.
End-to-end assistance for obtaining an Import Licence (Form MD-15) for in vitro diagnostic medical devices, including their software, reagents, calibrators, controls, components and accessories.
End-to-end assistance for obtaining a Manufacturing Licence (Form MD-5/MD-9) for in vitro diagnostic medical devices, including their software, reagents, calibrators, controls, components and accessories.
End-to-end assistance for obtaining a Sale Licence (Form MD-42) for the sale, stock or exhibition of in vitro diagnostic medical devices.
End-to-end assistance for obtaining a BIS Licence for domestically manufactured IVD products, where applicable.
End-to-end assistance for obtaining a BIS Licence for foreign manufacturers supplying regulated IVD products to the Indian market, where applicable.
End-to-end assistance for obtaining BIS Registration under the Compulsory Registration Scheme (CRS) for notified products.
End-to-end assistance for obtaining LMPC registration for manufacturers of pre-packaged IVD products.
End-to-end assistance for obtaining LMPC registration for importers of pre-packaged IVD products.
End-to-end assistance for securing trademark registration and protecting brands associated with IVD products.
End-to-end assistance for obtaining a Market Standing Certificate for IVD products from the relevant Central or State Licensing Authority.
End-to-end assistance for obtaining a Non-Conviction Certificate from the relevant Central or State Licensing Authority.
Comprehensive review of IVD labels to assess compliance with applicable labelling requirements.
Comprehensive review of product claims, promotional materials and advertisements to assess compliance with applicable laws.
End-to-end assistance for registration on the Integrated Pharmaceutical Database Management System (IPDMS) portal.
End-to-end assistance for submission of price lists in Form VI under the Drugs (Prices Control) Order, 2013.
End-to-end assistance for filing price fixation applications in Form I before the National Pharmaceutical Pricing Authority.
End-to-end assistance for filing price revision applications in Form II before the National Pharmaceutical Pricing Authority.
End-to-end assistance for submitting discontinuation intimations in Form IV to the National Pharmaceutical Pricing Authority.
End-to-end assistance for preparing and filing quarterly returns in Form III with the National Pharmaceutical Pricing Authority.
End-to-end assistance for obtaining Department of Pharmaceuticals approval for foreign advanced clinical training programmes.
End-to-end assistance for preparing and submitting marketing expenditure disclosures and self-declarations under the Uniform Code for Marketing Practices in Medical Devices.
End-to-end assistance for obtaining approval for foreign advanced clinical training of healthcare professionals under the Uniform Code for Marketing Practices in Medical Devices.
Industry
Clinical Trials
EnquireBusinesses engaged in the conduct, management, sponsorship and oversight of clinical investigations, clinical trials and biomedical research involving drugs, biological products and medical devices.
End-to-end assistance for obtaining permission to conduct clinical trials under the New Drugs and Clinical Trials Rules, 2019.
End-to-end assistance for obtaining approvals for addition or amendment of clinical trial sites under the applicable regulatory framework.
End-to-end assistance for obtaining registration of Ethics Committees under the New Drugs and Clinical Trials Rules, 2019.
End-to-end assistance for obtaining registrations and approvals required for hospitals and institutions functioning as clinical trial sites.
End-to-end assistance for obtaining registration of Bioavailability / Bioequivalence (BA/BE) study centres under the applicable regulatory framework.
End-to-end assistance for obtaining permission to import investigational new drugs for clinical trials.
End-to-end assistance for obtaining permission to manufacture investigational new drugs for clinical trials.
End-to-end assistance for obtaining approvals for export of human biological samples for testing and analysis, where applicable.
End-to-end assistance for securing trademark registration and protecting brands associated with clinical research organisations and clinical trial services.
Comprehensive review of labels for investigational products to assess compliance with applicable regulatory requirements.
Comprehensive review of clinical trial-related promotional materials and communications to assess compliance with applicable laws and ethical requirements.
End-to-end legal and regulatory assistance for compliance with reporting, investigation and compensation requirements relating to serious adverse events during clinical trials.
Industry
Hospitals
EnquireBusinesses engaged in providing preventive, diagnostic, therapeutic, surgical, rehabilitative and emergency healthcare services through hospitals and healthcare establishments.
End-to-end assistance for obtaining registrations and licences required for the establishment and operation of hospitals, nursing homes and other healthcare establishments under the applicable Central and State laws.
End-to-end assistance for obtaining empanelment of hospitals under the Central Government Health Scheme (CGHS) and Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) schemes.
End-to-end assistance for obtaining retail and wholesale drug licences for hospital pharmacies under the Drugs Rules, 1945.
End-to-end assistance for obtaining licences or authorisations for procurement, possession, storage and dispensing of essential narcotic drugs under the NDPS framework.
End-to-end assistance for obtaining registration of hospitals for organ and tissue transplantation under the Transplantation of Human Organs and Tissues Act, 1994.
End-to-end assistance for obtaining registration of Genetic Counselling Centres, Genetic Laboratories and Genetic Clinics under the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.
End-to-end legal and regulatory assistance for compliance with Form F and other record-keeping requirements under the PCPNDT Act and Rules.
End-to-end assistance for obtaining a licence in Form 28-C for the operation of a blood centre under the Drugs Rules, 1945.
End-to-end assistance for obtaining registrations, licences and approvals from the Atomic Energy Regulatory Board (AERB) for diagnostic and therapeutic radiation equipment.
End-to-end assistance for obtaining a Fire No Objection Certificate for hospital premises from the competent authority.
End-to-end assistance for obtaining statutory building approvals and occupancy certificates for hospital premises, where applicable.
End-to-end assistance for obtaining licences and statutory approvals for lifts and elevators installed in hospital premises, where applicable.
End-to-end assistance for obtaining licences from the Petroleum and Explosives Safety Organisation (PESO) for storage of liquid medical oxygen and other compressed gases, where applicable.
End-to-end assistance for regulatory approvals relating to hospitals functioning as clinical trial sites, where applicable.
End-to-end assistance for obtaining registration of Ethics Committees under the New Drugs and Clinical Trials Rules, 2019, where applicable.
End-to-end legal and regulatory assistance for obtaining and maintaining accreditation from the National Accreditation Board for Hospitals & Healthcare Providers (NABH).
End-to-end assistance for securing trademark registration and protecting brands associated with hospitals and healthcare services.
End-to-end assistance for obtaining registrations or filing registration / intimations under the applicable Shops and Establishments law governing hospitals and healthcare establishments in the relevant State or Union Territory.
Industry
Diagnostic Labs
EnquireBusinesses engaged in conducting pathological, microbiological, biochemical, genetic, radiological and other diagnostic examinations for disease detection, monitoring and clinical decision-making.
End-to-end assistance for obtaining registrations and licences required for the establishment and operation of diagnostic labs as an healthcare establishment under the applicable Central and State laws.
End-to-end assistance for obtaining CGHS empanelment for diagnostic labs and imaging centres under the Central Government Health Scheme (CGHS).
End-to-end regulatory and contractual support for diagnostic labs participating in Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB PM-JAY) service delivery arrangements.
End-to-end assistance for obtaining retail and wholesale drug licences for diagnotic labs for stocking of drugs and supplying to other facilities under the Drugs Rules, 1945.
End-to-end assistance for obtaining licences or authorisations for possession and storage of essential narcotic drugs under the NDPS framework.
End-to-end assistance for obtaining registration of Genetic Laboratories, ultrasound clinics, Imaging Centres conducting prenatal diagnostic procedures under the Pre-Conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act, 1994.
End-to-end legal and regulatory assistance for compliance with Form F and other record-keeping requirements under the PCPNDT Act and Rules.
End-to-end assistance for obtaining registrations, licences and approvals from the Atomic Energy Regulatory Board (AERB) for diagnostic and therapeutic radiation equipment.
End-to-end assistance for obtaining a Fire No Objection Certificate for diagnostic labs from the competent authority.
End-to-end assistance for obtaining statutory building approvals and occupancy certificates for diagnostic lab premises, where applicable.
End-to-end assistance for obtaining licences and statutory approvals for lifts and elevators installed in diagnostic labs, where applicable.
End-to-end assistance for obtaining licences from the Petroleum and Explosives Safety Organisation (PESO) for storage of liquid medical oxygen and other compressed gases in diagnostic lab, where applicable.
End-to-end legal, regulatory assistance for obtaining and maintaining accrediation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) under ISO 15189 for pathology, molecular, microbiology, biochemistry, genetic, radiology, imaging, and other medical diagnostic services.
End-to-end assistance for securing trademark registration and protecting brands associated with diagnostic labs.
End-to-end assistance for obtaining registrations or filing registration / intimations under the applicable Shops and Establishments law governing diagnostic labs in the relevant State or Union Territory.
End-to-end assistance for obtaining authorization under the Bio-Medical Waste Management Rules, 2016 from the concerned State Pollution Control Board.
End-to-end assistance for obtaining environmental consent for diagnostic labs using chemicals, effluents, or generating regulated waste from concerned State Pollution Control Board under the Water Act, 1974 and Air Act, 1981.
End-to-end assistance for obtaining and maintaining a valid tie-up with an authorized CBWTF operator approved by the concerned State Pollution Control Board for compliant collection, transportation, treatment, and disposal of biomedical waste.
Industry
Agriculture
EnquireBusinesses engaged in the cultivation, production, processing, storage, marketing and distribution of agricultural produce, seeds, fertilizers, pesticides and other agricultural inputs.
End-to-end assistance in securing trademark registration and protecting Agriculture brands.
Comprehensive review of agricultural products labels to assess compliance with applicable labelling requirements.
End-to-end support in obtaining LMPC registration for manufacturers of pre-packaged agriculture products under the Legal Metrology framework.
End-to-end regulatory assistance for obtaining LMPC registration for importers of pre-packaged agriculture products under the Legal Metrology framework.
End-to-end assistance for obtaining FSSAI Registration for agricultural products by eligible business operators for processing, packaging, storage, trading, export, or distribution of agricultural produce and food products under the Food Safety and Standards Act, 2006 including Tatkal registration mechanism, where applicable.
End-to-end assistance for obtaining an FSSAI State Licence for agricultural products by eligible business operators engaged in the manufacture, processing, storage, distribution or sale of food products, including through the Tatkal licensing mechanism, where applicable.
End-to-end assistance for obtaining an FSSAI Central Licence for for agricultural products by eligible business operators including importers, exporters and businesses falling under the jurisdiction of the Central Licensing Authority, including through the Tatkal licensing mechanism, where applicable.
End-to-end assistance for obtaining phytosanitary certificates, compliance, and related approvals for export of agricultural produce other plant products.
End-to-end assistance for obtaining licences for manufacture, import, sale, storage, wholesale, and retail distribution of fertilizers under the Fertilizer (Control) Order, 1985, including product approvals, dealer registrations, and ongoing compliance support.
End-to-end assistance for obtaining licences for manufacture, import, formulation, sale, stock, distribution, and use of insecticides and pesticides under the Insecticides Act, 1968 and the Insecticides Rules, 1971, including dealer, distributor, and retailer approvals.
End-to-end assistance for obtaining trader, commission agent, processor, warehouse, and market participant registrations under the relevant State Agricultural Produce Market Committee (APMC) laws for marketing and trading of agricultural produce
End-to-end assistance for obtaining registrations, licences, and approvals for warehouses, silos, godowns, and cold storage facilities under the Warehousing Development and Regulation framework and applicable State laws, including storage of agricultural commodities and perishables.
End-to-end assistance for obtaining plant quarantine permits, phytosanitary clearances, import permits, and compliance approvals for import of seeds, planting material, agricultural inputs, and other regulated plant products under the Plant Quarantine framework.
End-to-end assistance for obtaining APEDA registration-cum-membership certification for export of scheduled agricultural and processed food products, including compliance support for export-oriented agricultural businesses.
End-to-end assistance for obtaining organic certification under the National Programme for Organic Production (NPOP) or PGS-India, including farm conversion, documentation, inspection coordination, traceability systems, and labelling compliance.
End-to-end assistance for obtaining seed dealer, distributor, retailer, and producer registrations and licences under the Seeds Act, 1966 and the applicable State Seed Rules, including registration of seed processing units and compliance with seed quality and labelling requirements.
Industry
Environment & Waste Management
EnquireBusinesses engaged in environmental protection, pollution control, waste generation, collection, treatment, recycling, disposal and resource recovery activities regulated under environmental laws.
End-to-end assistance for obtaining Extended Producer Responsibility (EPR) Registration for plastic packaging under the Plastic Waste Management Rules, 2016.
End-to-end assistance for obtaining Extended Producer Responsibility (EPR) Registration under the Battery Waste Management Rules, 2022.
End-to-end assistance for obtaining Extended Producer Responsibility (EPR) Registration under the E-Waste (Management) Rules, 2022.
End-to-end assistance for preparing and filing annual EPR returns under the Plastic Waste Management Rules, 2016.
End-to-end assistance for preparing and filing annual EPR returns under the Battery Waste Management Rules, 2022.
End-to-end assistance for preparing and filing quarterly and annual EPR returns under the E-Waste (Management) Rules, 2022.
End-to-end assistance for developing awareness materials and conducting employee, dealer, distributor and consumer training programmes to ensure compliance with applicable Extended Producer Responsibility (EPR) obligations.
End-to-end assistance for obtaining Hazardous Waste Authorisation under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016.
End-to-end assistance for filing prior intimation for the import, export and movement of hazardous and other wastes under the Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016.
End-to-end assistance for obtaining Consent to Establish under the Water (Prevention and Control of Pollution) Act, 1974 and the Air (Prevention and Control of Pollution) Act, 1981.
End-to-end assistance for obtaining Consent to Operate under the Water (Prevention and Control of Pollution) Act, 1974 and the Air (Prevention and Control of Pollution) Act, 1981.
End-to-end assistance for obtaining Biomedical Waste Authorization under the Biomedical Waste Management Rules, 2016.
End-to-end assistance for preparation and filing of annual returns under the Biomedical Waste Management Rules, 2016.
End-to-end assistance for developing training materials and conducting awareness and compliance training programmes for healthcare personnel on the safe handling and management of biomedical waste in accordance with the Biomedical Waste Management Rules, 2016.
Industry
Alcohol & Tobacco
EnquireBusinesses engaged in the manufacture, import, distribution, sale and marketing of alcoholic beverages, tobacco products and nicotine-containing products regulated under applicable laws.
End-to-end assistance in securing trademark registration and protecting pharmaceutical brands.
Comprehensive review of medical device labels to assess compliance with applicable labelling requirements.
End-to-end support in obtaining LMPC registration for manufacturers of pre-packaged medical devices under the Legal Metrology framework.
End-to-end regulatory assistance for obtaining LMPC registration for importers of pre-packaged medical devices under the Legal Metrology framework.
End-to-end assistance for obtaining FSSAI Registration for eligible food business operators under the Food Safety and Standards Act, 2006, including through the Tatkal registration mechanism, where applicable.
End-to-end assistance for obtaining an FSSAI State Licence for food business operators engaged in the manufacture, processing, storage, distribution or sale of food products, including through the Tatkal licensing mechanism, where applicable.
End-to-end assistance for obtaining an FSSAI Central Licence for eligible food business operators, including importers, exporters and businesses falling under the jurisdiction of the Central Licensing Authority, including through the Tatkal licensing mechanism, where applicable.
Industry
Drones & Robots
EnquireBusinesses engaged in the design, manufacture, import, operation and commercialization of unmanned aircraft systems, robotic devices and autonomous technologies.
End-to-end assistance for obtaining DGCA Type Certification for unmanned aircraft systems (UAS) under the Drone Rules, 2021
End-to-end assistance for obtaining import approvals, DGCA clearances, DGFT compliance, customs documentation, and related regulatory support for import of drones, unmanned aircraft systems, drone components, payloads, sensors, and associated equipment into India
End-to-end assistance for registration and compliance support for drone manufacturers under the Drone Rules, 2021
End-to-end assistance for obtaining Equipment Type Approval (ETA), wireless import permissions, RF compliance approvals, and spectrum-related clearances from the Wireless Planning & Coordination Wing (WPC) for drone communication modules, telemetry systems, GNSS receivers, and wireless robotic equipment.
End-to-end assistance for obtaining BIS certification, registration under Compulsory Registration Scheme (CRS), electronics safety certification and conformity assessment for drones, robotic systems, batteries, chargers, controllers, communication devices, and other notified electronic components.
End-to-end assistance for obtaining IEC from DGFT for import and export of drones, robotic systems, components, sensors, batteries, software-enabled hardware, and related technology products.
End-to-end support in obtaining LMPC registration for manufacturers of pre-packaged drones or robotes or its components, accessories, spare parts under the Legal Metrology framework.
End-to-end regulatory assistance for obtaining LMPC registration for importers of pre-packaged drones or robotes or its components, accessories, spare parts under the Legal Metrology framework.
End-to-end support in securing trademark registration and protecting brands associated with drones or robotes or its components, accessories, spare parts.
Industry
Traditional Medicines
EnquireBusinesses engaged in the manufacture, import, sale and distribution of Ayurvedic, Siddha, Unani, Homoeopathic and other traditional medicinal products regulated under applicable laws.
End-to-end assistance for obtaining a Manufacturing Licence to manufacture Ayurvedic, Siddha or Unani drugs for sale or distribution under the Drugs Rules, 1945.
End-to-end assistance for obtaining a Manufacturing Licence to manufacture Homoepathic drugs for sale or distribution under the Drugs Rules, 1945.
End-to-end assistance for obtaining a Loan Licence for manufacturers who do not have their own manufacturing facility but intend to avail third-party manufacturing arrangements for ASU drugs.
End-to-end assistance for obtaining a Loan Licence for manufacturers who do not have their own manufacturing facility but intend to avail third-party manufacturing arrangements for Homoepathic drugs.
End-to-end assistance for obtaining a Good Manufacturing Practices Certificate under Schedule T for Homoepathic drug manufacturing units
End-to-end assistance for obtaining a Good Manufacturing Practices Certificate under Schedule T for ASU drug manufacturing units
End-to-end support for obtaining licences to sell, stock, exhibit or distribute Ayurvedic, Siddha and Unani drugs at wholesale and retail level.
End-to-end support for obtaining licences to sell, stock, exhibit or distribute Homoeopathicdrugs at wholesale and retail level.
Comprehensive review of Ayurvedic, Siddha, Unani and Homoeopathic product labels to assess compliance with Schedule requirements under the Drugs and Cosmetics Rules.
Comprehensive review of Ayurvedic, Siddha, Unani and Homoeopathic product labels to assess compliance with Schedule requirements under the Drugs and Cosmetics Rules.
End-to-end support in securing trademark registration and protecting brands associated with traditional medicine products.
End-to-end support in obtaining LMPC registration for manufacturers of pre-packaged ASU&H products under the Legal Metrology framework.
End-to-end regulatory assistance for obtaining LMPC registration for importers of pre-packaged ASU&H products under the Legal Metrology framework.
Industry
Animal Health & Wildlife
EnquireBusinesses engaged in veterinary healthcare, manufacture and distribution of veterinary products, animal biotechnology, wildlife conservation and activities involving protected fauna regulated under applicable laws.
End-to-end assistance for obtaining registrations and licences required for the establishment and operation of a veterinary hospital as a healthcare establishment under the applicable Central and State laws issued by the State Animal Husbandry Department, Veterinary Council authority, or Health Department.
End-to-end assistance for obtaining retail and wholesale drug licences for veterinary pharmacies under the Drugs Rules, 1945.
End-to-end assistance for obtaining licences or authorisations for procurement, possession, storage and dispensing of essential narcotic drugs for veterinary use under the NDPS framework.
End-to-end assistance for obtaining a licence for the operation of a veterinary blood centre under the Drugs Rules, 1945.
End-to-end assistance for obtaining registrations, licences and approvals from the Atomic Energy Regulatory Board (AERB) for diagnostic and therapeutic radiation equipment used in veterinary facilities.
End-to-end assistance for obtaining a Fire No Objection Certificate for veterinary hospital premises from the competent authority.
End-to-end assistance for obtaining statutory building approvals and occupancy certificates for veterinary hospital premises, where applicable.
End-to-end assistance for obtaining licences and statutory approvals for lifts and elevators installed in veterinary hospital premises, where applicable.
End-to-end assistance for obtaining licences from the Petroleum and Explosives Safety Organisation (PESO) for storage of liquid medical oxygen and other compressed gases at veterinary hospital premises, where applicable.
End-to-end assistance for regulatory approvals relating to veterinary hospitals functioning as clinical trial sites, where applicable.
End-to-end assistance for obtaining registration of Ethics Committees for veterinary clinical research under the applicable regulatory framework, where applicable.
End-to-end legal and regulatory assistance for obtaining and maintaining accreditation from the National Accreditation Board for Hospitals & Healthcare Providers (NABH) for veterinary healthcare facilities.
End-to-end assistance for securing trademark registration and protecting brands associated with veterinary healthcare, animal health products and wildlife services.
End-to-end assistance for obtaining registrations or filing registration / intimations under the applicable Shops and Establishments law governing veterinary hospitals and animal healthcare establishments in the relevant State or Union Territory.
End-to-end assistance for obtaining FSSAI registration or licence for businesses engaged in the sale or dispensing of animal food, pet food, and veterinary nutritional products under the Food Safety and Standards Act, 2006.
End-to-end assistance for obtaining registrations and licences required for the establishment and operation of a veterinary diagnostic lab as a healthcare establishment under the applicable Central and State laws.
End-to-end legal and regulatory assistance for obtaining and maintaining accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) under ISO/IEC 17025 for veterinary medical diagnostic services.
End-to-end assistance for obtaining registrations and licences required for import / export of wildlife, specimens, tissues, trophies from relevant state and central department.
End-to-end assistance for obtaining registrations and licences required for establishing and maintaining Wildlife rescue & rehabilitation centre from relevant state and central department.
End-to-end support in obtaining LMPC registration for manufacturers of pre-packaged medical devices for animals under the Legal Metrology framework.
End-to-end regulatory assistance for obtaining LMPC registration for importers of pre-packaged medical devices for animals under the Legal Metrology framework.
End-to-end legal and regulatory assistance for registration on the Integrated Pharmaceutical Database Management System (IPDMS) portal.
End-to-end legal and regulatory assistance for submission of price lists in Form V under the Drugs (Prices Control) Order, 2013.
End-to-end legal and regulatory assistance for submission of price lists in Form VI under the Drugs (Prices Control) Order, 2013.
End-to-end legal and regulatory assistance for filing price fixation applications in Form I before the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for filing price revision applications in Form II before the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for submitting discontinuation intimations in Form IV to the National Pharmaceutical Pricing Authority.
End-to-end legal and regulatory assistance for preparing and filing quarterly returns in Form III with the National Pharmaceutical Pricing Authority.
End-to-end assistance for obtaining No Objection Certificate from Department of Animal Husbandry and Dairying for medical devices approved for animal use including their software, spare parts, components and accessories where no predicate device is available.
End-to-end assistance for obtaining an Import Licence (Form MD-15) for medical devices approved for animal use including their software, spare parts, components and accessories.
End-to-end assistance for obtaining a Registration Certificate for manufacturers and importers of class A non-sterile and non-measuring medical devices approved for animal use.
End-to-end assistance for obtaining a Manufacturing Licence (Form MD-5/MD-9) for medical devices approved for animal use, including their software, spare parts, components and accessories.
End-to-end support for obtaining a wholesale registration (Form MD-42) for the sale, stock or exhibition of medical devices approved for animal use.
End-to-end support in obtaining a Market Standing Certificate for medical devices approved for animal use from the relevant Central or State licensing authority.
End-to-end assistance for obtaining a Non-Conviction Certificate from the relevant Central or State licensing authority.
Comprehensive review of medical device labels approved for animal use to assess compliance with applicable labelling requirements.
Assistance in obtaining the approval of risk class for the medical devices used in animals in order to import, manufacture such devices in India from concerned state or central licensing authority.
End-to-end legal and regulatory assistance for obtaining Department of Pharmaceuticals approval for foreign advanced clinical training programmes.
End-to-end legal and regulatory assistance for preparing and submitting marketing expenditure disclosures and self-declarations under the Uniform Code for Marketing Practices in Medical Devices used in animals.
End-to-end legal and regulatory assistance for obtaining approvals for foreign advanced clinical training of healthcare professionals under the UCMPMD framework.
Industry
Battery
EnquireBusinesses engaged in the manufacture, import, sale, recycling, refurbishment and end-of-life management of batteries and battery energy storage systems.
End-to-end assistance for obtaining Extended Producer Responsibility (EPR) Registration under the Battery Waste Management Rules, 2022.
End-to-end assistance for preparing and filing annual returns under the Battery Waste Management Rules, 2022.
End-to-end assistance for obtaining registration as a recycler or refurbisher under the Battery Waste Management Rules, 2022.
End-to-end assistance for obtaining a BIS Licence for domestically manufactured batteries and battery products covered under applicable Quality Control Orders.
End-to-end assistance for obtaining a BIS Licence under the Foreign Manufacturers Certification Scheme (FMCS) for notified batteries and battery products intended for the Indian market.
End-to-end assistance for obtaining BIS Registration under the Compulsory Registration Scheme (CRS) for notified batteries and battery products, where applicable.
End-to-end assistance for securing trademark registration and protecting brands associated with batteries and energy storage products.
Comprehensive review of battery labels to assess compliance with applicable labelling and marking requirements.
Comprehensive review of product claims, technical specifications, promotional materials and advertisements to assess compliance with applicable laws.
End-to-end assistance for obtaining LMPC Registration for manufacturers of pre-packaged batteries and battery products.
End-to-end assistance for obtaining LMPC Registration for importers of pre-packaged batteries and battery products.
End-to-end legal and regulatory assistance for compliance with UN Manual of Tests and Criteria, Part III, Sub-section 38.3 for transportation of lithium batteries.
End-to-end legal and regulatory assistance for ensuring compliance with labelling and marking requirements under the Battery Waste Management Rules, 2022 and other applicable laws.