Custom Peptide Synthesis
Peptide CMC
Catalog Peptides
cGMP Peptide APIs Manufacturing
CMC filing
Service overview:
Biopeptek’s regulatory team offers documentation support for IND and NDA applications globally. Our team has
experience preparing Module 2 and Module 3 of your regulatory dossier.
- Batch record review
- Document management and control
- Deviations/Investigations
- CAPA follow-up and tracking
- Complaint management
- Product release
- Phase appropriate control systems consulting
- CMC compilation
- DMF compilation and submission
- Annual product reviews
