DRUGS REGULATORY SERVICES IN INDIA
Auxilife offers comprehensive solution for registrations in accordance with Drugs and Cosmetics Act, 1940 and Rules, 1945. Our best team of experts will provide you the strategic guidance on list of data requirements and the process for various registrations for import and manufacture of formulation and bulks drugs.
Key Services
- Approval for NDA (New Drug Approval).
- Approval for IND (Investigational new drug).
- Approval Subsequent drug approval (SND).
- To obtain test license.
- To seek Permission for Clinical trials.
- Write toxicity and quality overall summaries.
- Prepare presentations for the SEC (subject expert committee).
- Comprehend the recommendations given by the TRC (technical review committee).
- Support Dossier preparation and submission.
- Extend Post submission support.