As a company, we have one of the largest number of briefs on Diagnostics & Medical Devices Regulatory work. We combine this with our in-depth knowledge of drug regulations and help our clients in preparation of pamphlets, brochures, etc. and ensure they are as per the guidelines prescribed by various government departments. Besides this, we also help our clients in preparing dossiers for obtaining ...

15.However, detailed guidance documents should be prepared providing the requirements and adequacy of global clinical data that can be considered for approval of any new drug in the country in both the cases where India was one of the participating countries in the global clinical trial or in cases where India was not a participating country. 16.The sponsor intending to submit NDA to CDSCO for mar ...