Regulatory Compliance & GAP Analysis
- GAP Analysis
- Liaison for DCGI licensing & FDA, CDSCO activities
- Outsourcing Support
- Pharma Regulatory Filing Support
- Site Master File Preparation
- Drug Substance and Product Registration Dossier Preparation
- Drug Firm Establishment Registration & Electronic Submissions
- Drug Master File (DMF) Preparation
- Critical Dossier Review
- Compliance Audits
