We provide bespoke services in the fields of automated and computerized systems engineering, quality, GxP compliance and Data Integrity.
4 reasons to choose Pharmasys:
We are exclusively dedicated to the life sciences industries.
Our services are perfectly tailored to fit your requirements.
Our methods are built on ISPE guidelines.
Results are guaranteed.
PHARMASYS has established itself in new practices in terms of GxP compliance based on the risk analysis approach put forward by the FDA at the end of 2003 and through the FDA’s « cGMP’s for the 21th century » initiative which has generated a whole new framework of guidelines and methods.
- 21 CFR Part 11 New guidance, 2003
- Annex 11 GMP
- ICH Q9 Risk Analysis
- GAMP 5, 2008 & ASTM E 2500
- Data Integrity guidances : FDA, MHRA, PIC’s, WHO
Every PHARMASYS employee has expertise in 3 core areas – regulatory, methodological and operational, guaranteeing a holistic approach to your requirements.