Regulatory
Through our European partner, we deliver specialized EU-market regulatory services, including:
- Pharma Lab & Factory Design
- Clean Room & Critical Environment Setup
- GMP Audits (QP/EU Authority) & ICH Q3D Compliance
- Microbiology, Physicochemical & Stability Study Support
- EU Documentation & Registration Assistance
- Import Lab Services: warehousing, sampling, analysis, release & distribution of FDF & raw materials
- OTC & Generic Product Launch Support, including API & pharma product marketing