Comprehensive IND & NDA Regulatory Support

Sinopep delivers end-to-end regulatory expertise for U.S. and global IND and NDA submissions, ensuring seamless compliance and successful approval of your peptide APIs.

• Full batch record review and certification
• Secure document management and version control
• Deviation investigations and root-cause analysis
• CAPA development, implementation, and tracking
• Complaint handling and resolution
• Final product release and CoA issuance
• Phase-appropriate quality system design and consulting
• CMC sec