Regulatory Affairs
Registration
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.