Our Quality System
Built for Regulatory Excellence
25 years of inspection-readiness, zero critical FDA observations, and a QMS that exceeds ICH Q10 requirements.
ICH Q10 Quality System
Pharmaceutical Quality System spanning product development through commercial manufacture and discontinuation.
✓ Change management CAPA
✓ Product quality reviews
✓ Knowledge management
Regulatory Compliance
Continuously maintained compliance with FDA 21 CFR Parts 210/211, EU GMP Annex 1, and ICH Q7 for APIs.
✓ FDA registered facility
✓ EMA GMP certificate
✓ PMDA & MHRA approved
Inspection Track Record
25 years of FDA, EMA, and national authority inspections with consistently excellent outcomes.
0
Critical FDA Observations, Ever