Quality & Certs
Certified Quality, Full Traceability
Every batch is documented, tested, and released under GMP conditions.
ISO 9001:2015
Quality management system certified across the manufacturing campus.
GMP Certified
Current Good Manufacturing Practice for peptide APIs and finished goods.
FDA Registered
US FDA-registered facility with batch-level traceability.
ICH Q7
Active pharmaceutical ingredient manufacturing aligned to ICH Q7.
REACH Compliant
EU chemical regulation documentation available on request.
CoA Guaranteed
HPLC, MS, and full Certificate of Analysis with every shipment.
CoA Authenticity Verification
Instantly verify the authenticity of any Monarabiotch Certificate of Analysis. Our real-time QMS database ensures every document is traceable and tamper-proof.