There is multiple/ample numbers of Authorities in India that regulate Life sciences in India amongst which one of the most important is the Ministry of Science & Technology.

Our services

Our Firm represents a number of biotech and pharmaceutical companies, medical device manufacturers, and clinical research organizations with the competence to advise on sector specific critical legal issues including:

• Permissibility of ingredients and product formulations under food and drug laws.
• Legal and regulatory issues relating to clinical trials, informed consent of the clients and other documentation, presentations before the ethics committees, reporting of completion of studies, and adverse drug reactions.
• Financial and technology collaboration between entities within the sector, financing, and acquisitions with tax-efficient structures.
• Drafting and negotiation of agreements governing the distribution, outsourcing, franchising, marketing, licensing, and consulting of pharmaceuticals and medical devices, and establishment of research and development facilities in India.
• Compliance with data protection and privacy covenants and conditions and confidentiality of results as well as records.
• Avoidance and resolution of product liability disputes by the process of litigation and mediation.
• Proposed regulatory and legislative changes, by submitting suggestions and opinions with the expert committees and the Government.
• All the Aspects of professional ethics guidelines, governing the conduct of physicians in the recruitment of subjects for clinical trials and in the dissemination of information about new drugs and medical devices in the market.
• All stages of regulatory compliance’s and defense of enforcement actions and investigations conducted against it.