Zach System is a CDMO company located in Avrille, France specialized in the production in exclusivity of Active Pharmaceutical Ingredients (API) from Phase I/II to Commercial quantities. Our DNA is to accompany our customers all along the process development activity, the scale-up phases, the validation of processes read moreand method of analysis and the DMF filing.

We are compliant with the highest international standards being inspected by Regulatory Authorities like FDA (USA), ANSM (France), PMDA (Japan), MFDS (Korea). We are also regularly audited by our customers comprising major pharmaceutical and biotech companies. Our plant is also ISO 14001 certified.

In terms of manufacturing capabilities under GMP, we have the possibility to handle API having an OEL down to 1µg/m3 using different equipment size:

• A Kilolab plant with 2 reactors (15 lt and 30 lt) and an agitated nutsche filter
• A Pilot plant with a total capacity of 5m3 with 11 reactors from 100L to 1000L)
• 2 commercial workshops (reactors in GL and SS from 1m3 to 10m3) allowing us to produce API from 100kg to 150MT/year

We also have special technologies available on site like Spray-Drying, Nano and Ultra-Filtration giving us the possibility to purify macromolecules (peptides like, Carbohydrates, Cyclodextrins, Aminoacid derivatives). [website]