Regulatory And Dossier Support

Ambix, has successfully submitted 250+ dossiers across 20+ countries, with many more currently in progress.

Our Regulatory Affairs Department plays a pivotal role in ensuring that all pharmaceutical products meet the stringent regulatory requirements of global health authorities. We act as a bridge between your product development, manufacturing processes, and market entry,
ensuring full compliance with applicable laws and guidelines for successful product registration and commercialization.

1. Dossier Preparation and Submission
o Comprehensive dossier preparation in CTD, eCTD, ACTD & Country Specific
formats.
2. Product Registration and Market Authorization
o End-to-end support for obtaining product licenses in international markets.
o Managing renewals, variations, and amendments for continued compliance.
3. Regulatory Compliance and Documentation
o Developing and maintaining technical documents: batch records, validation
protocols, stability data, and product information leaflets.
o Ensuring labelling and packaging meet region-specific guidelines.
4. Liaison with Regulatory Authorities
o Responding to queries, deficiency letters, and audits.
o Coordinating pre- and post-approval interactions to ensure swift resolutions.
5. Post-Approval Regulatory Support
o Lifecycle management of approved products, including post-market surveillance,
variation filings, and license renewals.

Our Regulatory Affairs Department ensures that every product complies with the highest regulatory standards, helping you navigate complex regulatory landscapes with efficiency and precision. We are committed to delivering solutions that ensure timely approvals, maintain market presence, and uphold product quality and safety across global markets.