Pharmaceuticals & Biotechnology

AZB & Partners’ comprehensive understanding of the pharmaceutical, medical devices, biotech and food industries has established it as the preferred legal partner for all related matters. We are able to successfully help clients navigate the complex regulatory framework that governs this space.

The Firm rich roster of clients includes various pharmaceutical, medical devices / biotech companies and companies in the food and beverages industry, both in India and abroad.

The Firm advises clients on a host of matters such as structuring transactions, conducting intellectual property and regulatory due diligence, drafting and negotiating transaction documents. AZB & Partners also works with and assists pharmaceutical, medical device and diagnostic companies on regulatory compliance, obtaining of requisite licenses and global players on their India entry strategy. The Firm has advised global medical device manufacturers on strategies aligned with the recent pricing regulations imposed by the NPPA and as assisted bio-pharmaceutical companies on obtaining import licenses for drugs on a ‘compassionate use’ basis.

Our work includes:

  • Advising clients in the pharma and healthcare sectors on their acquisitions, sale of stake and / or transfer of part of its business
  • Advising clients on intellectual property licensing and technical collaborations, as well as acquisition of pharmaceutical brands
  • Conducting audits of the intellectual property portfolio of pharmaceutical and biotech companies
  • Delivering drug and medical device regulatory and compliance advice including advising clients on obtaining marketing authorizations and import registrations
  • Advising pharmaceutical and medical device companies in relation to drug and medical device pricing issues, clinical trials, and clinical trial compensation regulations, as well as clinical trial agreements, informed consent forms and other reporting obligations including adverse events reporting
  • Advising pharmaceutical, medical device and diagnostic companies on various ethical issues, including those surrounding interactions with medical practitioners and compliance with advertising and marketing codes
  • Advising food and beverage manufacturers on the proprietary food regulatory landscape in India including laws governing import of proprietary foods into India, advertisement, labelling and packaging of foods products and issues relating to food safety standards and requirements

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