Radhika Patle

Radhika is a regulatory specialist with deep understanding of the regulatory framework that governs health-focused businesses, advising clients across licensing and compliance matters.

• Preparation of import licence applications, price-control registrations, and Conducted regulatory due diligence for hospitals.
• Appearance before various regulators such as CDSCO, NPPA, LM, CPCB, MPCB and has gotten solutions for Client in complex matters.
• Preparation of technical documentation for submissions to Indian regulatory authorities, including Plant Master Files and Device Master Files for medical device companies, and has advised hospitals on various regulatory compliance requirements.
• Advice on the regulatory pathways for the import of accessories and software as medical devices, including risk classification and predicate analysis. Her experience also extends to WPC-ETA approvals, ensuring seamless imports for devices requiring wireless authorizations.

• Bar Council of India

• Thomson Reuters Best In-House Counsel
• Chambers Ranked Firm

• Conducted HR Sutra Digital Master Class on EPR Framework
• In-Person Training on Biomedical Waste Compliances