With a long tradition manufacturing active pharmaceutical ingredients, ISOCHEM established very early a common Quality Assurance System to all its R&D and manufacturing sites. All sites are now certified Iso 9001:2000.

ISOCHEM's productions are performed in accordance with customer's requirements in terms of Quality, the most stringent being the Pharmaceutical Industry's criteria. Active Pharmaceutical Ingredients and registered intermediates are produced according to the current Good Manufacturing Practices (cGMP) in facilities regularly audited by our customers and inspected by Authorities such as the US Food and Drugs administration (FDA) and the French Agency AFSSAPS.

ISOCHEM presently operates 3 of its manufacturing plants according to cGMP (as defined in ICH-Q7) and 2 of them regularly are inspected by the FDA.

Total: 14 FDA audits
The latest FDA audit of ISOCHEM in August 2006 was complete success (No 483 form), proving the maturity and efficiency of our quality management system.

NEWS "French agency AFSSAPS currently audits ISOCHEM: API portfolio. AFSSAPS has delivered a cGMP certificate to all products already audited in 2007 (14 out of 25 API)".

In parallel, ISOCHEM brings all the necessary regulatory support such as registration of new sustances or DMF filing. More than 20 DMF groups were filed by ISOCHEM.