Computerized systems engineering, quality, compliance

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.

  • 21 CFR Part 11 guidance
  • GMP Annex 11
  • ICH Q9 Risk Analysis
  • GAMP 5, 2008
  • ASTM E 2500
  • Data Integrity guidances : FDA, MHRA, PIC’s, WHO

Thanks to the relevance of its interventions in consulting, audit and training,  PHARMASYS has since known a rapid development that continues unabated :

  • In 2008 PHARMASYS settled in Lyon
  • In 2009 PHARMASYS settled in Toulouse
  • In 2012 PHARMASYS settled in Switzerland through its subsidiary PHARMASYS CH and in Belgium
  • In 2013 PHARMASYS partnered with Polarion Life Sciences editor and proposes to his clients the Polarion Life Sciences solution for requirements traceability.

 PHARMASYS today

  • Thousands of leveraged consulting days of advice with employees with a unique experience
  • More than 75 customer references – large companies or smaller ones requiring pragmatism
  • An international presence