REGULATORY SERVICES
We help pharmaceutical companies to register the Medicinal products and gain regulatory approvals worldwide.
We help with the following submissions.
Drug Substance Services
- Authoring CMC Module 3 and Module 2.3 (QOS)
- DMF – Drug Master File
- CEP -Certificate of European Pharmacopoeia
- MF - Japan Master File Registration (DMF)
- AFM/FMA -Accreditation of Foreign Manufacturer (Japan)
- Response to health authority questions
- CMC – Gap analysis
Drug Product Services
- Authoring CMC Module 3 and Module 2.3 (QOS)
- JNDA -Japan – New Drug Application
- BLA -Biologics License Application
- MAA – Marketing Authorization Application
- ANDA - Abbreviated New Drug Application
- NDA -New Drug Application
- IND - Investigational New Drug
- Briefing book
- Scientific Advisory Meeting
- CMC Gap Analysis
Post Approval life cycle maintenance
FA Pharma has extensive experience in post-approval lifecycle maintenance activities to submit the post approval variations.
- MCN-Minor Change Notification (Japan)
- PCN -Partial Change Notification (Japan)
- CBE-0/CBE-30/PAS, PMCs, Type I/II Variations
- PACMP – Post Approval Change Management Protocols
- AFM/FMA -Accreditation of Foreign Manufacturer (Japan)
- Response to Health Authority Questions
- Manufacturing Site Transfers
GMP/Quality Compliance
GMP inspection /Audits
Warehouse, Distribution, Storage of products
Experience in reviewing the GMP documents/ source documents, analytical method validations protocols, reports, batch manufacturing records (BMR) and manufacturing process validations protocols and reports.