Regulatory Compliance
- Preparation of Drug Substance and Drug product registration dossier
- Dossier Preparation & Submissions in CTD
- Drug Firm Establishment Registration
- NDC [National Drug Code] and Electronic submission
- Preparation of DMF [Drug Master Files]
- Critical Review of Dossiers
- Compliance audits as per current and updated statutory pharma regulations
- GAP Analysis
- Liaison for DCGI licensing & FDA, CDSCO activities
- Support in Outsourcing Manufacturing or Testing Laboratories for Clients
- Strategic assistance in Pharma Regulatory filing
- Drug Listing in SPL [Structured Product labelling] format, Bulk Drug Listing
- Support in Outsourcing Manufacturing or Testing Laboratories for Clients
- Site Master file as per Local FDA requirement
- US FDA Compliance & Audit Support
Inspection readiness, audit backroom coordination, gap assessments, and FDA 483/Warning Letter response support.
Waaree
Gujarat, India
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