MUMBAI
Shabnam Sheikh
Legal Associate
B.A. LL.B (Hons), LL.M (Corporate Laws)
Shabnam is a regulatory specialist helping healthcare and allied sectors secure licenses and stay compliant. She's recognized as a trusted expert for sensitive, strategy-driven regulatory matters.
Biography
Shabnam is a regulatory specialist helping healthcare and allied sectors secure licenses and stay compliant. She is recognized as a trusted expert for sensitive, strategy-driven regulatory matters.
Areas of expertise
- Medical Devices
- Environment
Achievements
- 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.
Professional memberships
- Bar Council of India
Recognition and rewards
- Thomson Reuters Best In-House Counsel
- Chambers Ranked Firm
Publications and presentations
- Conducted HR Sutra Digital Master Class on EPR Framework
- In-Person Training on Biomedical Waste Compliances