High-quality formulation with proven bioequivalence
• API and FDF integrated development
• EU GMP & EAEU GMP production support
• Fast-track registration support in CIS, MENA, Asia
Manufacturing Capabilities:
• Pilot to commercial scale batches
• Analytical method transfer & validation
• Full documentation and tech transfer package
Holder Pharm Services:
• Contract development & manufacturing
• Regulatory support & BE study coordination
• Supply chain management from China to your market
