Successful regulatory approvals and timely product launches require sound strategic planning and thorough knowledge of the legislation. Additionally biotech products in India, particularly the recombinant biologics, DNA vaccines and genetically modified (GM) pharma products, face complex maze of approval and regulatory procedures with various authorities and bodies. The regulatory team at Krishna & Saurastri Associates having legal and technical background provide timely counseling and consultancy at various stages of food, drug, and medical device approvals to proactively identify and avoid any pitfalls and delays.
Our regulatory services include:
Strategic Consulting and Advisory services
We advise companies on regulatory issues related to,
 Importation of New Drugs, Generic Drugs and Medical Devices in India.
Providing guidance on legal and technical requirements on importation and marketing of Biotechnology products.
Importations of Nutraceutical, Dietary Supplements and Functional foods.
Complying with procedural and legal requirements for conducting clinical trials of Drugs & Medical Devices.
This includes assistance in finding out suitable Center and Investigator for Clinical trials.
Desk-based research to asses the regulatory environment and precedents for your particular product.
Co-coordinating with Regulatory Authorities
Conduct formal and Informal meetings, discussion with regulatory agencies.
Prepare responses to regulatory agencies.
Preparation and submission of documents to Regulatory authorities for
Market Authorisation of New Drugs, Generic Drugs and Medical Devices.
Clinical Trial Applications.
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REGULATORY APPROVAL FOR FOOD, DRUGS & MEDICAL DEVICES