Experts in evolving life science regulations. We help you choose the optimal regulatory pathway while avoiding pitfalls, leveraging experience from work inside global health agencies and close collaboration with authorities.
Our Regulatory Services
- Preparation of Drug Substance and Drug Product registration dossiers
- CTD submissions, DMF preparation, and dossier reviews
- Drug Firm Establishment Registration, NDC and electronic submissions
- Compliance audits and GAP analyses
- Liaison for DCGI licensing & FDA/CDSCO activities
- Structured Product Labeling and Site Master Files
- Preparation of DMF (Drug Master Files)
- Critical Review of Dossiers
- Outsourcing Support
- Strategic Pharma Regulatory Filing
