Quality
Appropriate Quality:
ISOCHEM's quality system based on a long experience working with the guidelines of various markets is designed to meet the exact quality standard required by your market.
Global Quality System :
ISOCHEM established, a global Quality System which complies with internal policies as well as with national and international standards (e.g. ISO) and regulations (e.g. cGMP).
Our certifications :
| Gennevilliers | Pithiviers | Vert-Le-Petit | Pont de Claix | Framochem | |
|---|---|---|---|---|---|
| ISO 9001 : 2008 | √ | √ | √ | √ | √ |
| cGMP (Q7) | √ | √ | √ | ||
| Inspected by the FDA | √ | √ | |||
| ISO 14401 | √ |
cGMP standards
With a long tradition of manufacturing active pharmaceutical ingredient and regulatory intermediates, ISOCHEM is able to manage your project according to the best practices
In addition, ISOCHEM brings all necessary regulatory support such as registration of new substances through IND or DMF filing in CTD format. More than 35 DMF were filed by ISOCHEM in different countries.
