Regulatory and quality compliance services and export report
- Conversion of data or document or dossier to country specific or ACT to CTD and vice versa and analysis of gap.
- Assessing the documents and existing dossier
- Site due diligence for Active Pharmaceutical Ingredients (API) site and Finished Product (FP) site and GMP compliance
- Assisting and providing guidance on adequate and relevant data generation for the submission of dossier successfully to country specific regulatory Authorities.
Post- Registration services
We provide post-approval regulatory changes to ourcustomers and assist themin addressing variations (major, minor or critical). We help updateexisting documents as per the country-specific regulatory requirements. We also provide assistance in the extension of labels and shelf-life.