Regulatory Affairs

Registration‚Äč

Product Registration involves Dossier Preparation in CTD, ACTD and Country Specific formats. Preparation of QA Documentation of Products. 

Renewal

Renewal dossier of preparation and submission as per country guidelines

Life Cycle Management

Life cycle management involves Major and Minor variation filing as per country requirement.


Legal Applications

License applications of Product permission, COPP, FSC, Marketing certificate, GMP Applications and others.

 

Query Responses

Compliances of all queries received during Registration, Renewal, Variation of Regulatory authorities.