Systems GxP, data integrity, quality, validation
History and key figures
PHARMASYS was created in 2005 by Jerome Larfi with the idea – which was also shared with the FDA – that the methods of the market players were inefficient and obsoletes.
Since the beginning, PHARMASYS has established itself in new practices in terms of compliance GxP based on the Risk Analysis approach as it was impulsed by the FDA at the end of 2003. The FDA « cGMP’s for the 21th century » method generated a whole new frame of guidelines and methods :
- Data Integrity GMP guidances : FDA, MHRA, PIC’s, WHO
- Annexe 11 GMP, 2011
- FDA 21 CFR Part 11 guidance 2003
- GAMP 5, 2008 & ASTM E 2500
- ICH Q9 Risk Analysis
Thanks to the relevance of its interventions in consulting, audit and training, PHARMASYS has since known a rapid development that continues unabated :
PHARMASYS settled in Lyon
PHARMASYS settled in Toulouse
PHARMASYS settled in Switzerland through its subsidiary PHARMASYS CH and in Belgium
PHARMASYS partnered with Polarion Life Sciences editor and proposes to his clients the Polarion Life Sciences solution for requirements traceability
PHARMASYS elected to TOP500 of fastest growing French companies
PHARMASYS (again) elected to TOP500 of fastest growing French companies
- A European leader in consulting for GxP digital: data integrity, quality and compliance.
- Dozens of employees capitalizing on unique expertise to support our clients Pharma, DM for their digital transformation.
- More than 75 references – from larger groups to smaller companies.
As part of our development, we are strengthening our teams.