Quality / EHS

World-class quality you can rely on

The ZaCh System approach to 360 degree support is completed by advanced multipurpose manufacturing facilities, strengthened by a regulatory culture that has achieved 20 years of successful FDA inspections:

  • The Avrille facility was first inspected in 1984 and has been successfully inspected almost yearly since 2000 by various regulatory agencies. Out of more than 25 years of operations, its regulatory history has been outstanding. No form 483 since 2010. Last inspection October 2014.

Consequently, whatever your requirements, we can help you achieve your objectives from beginning to end. All our plants are cGMP compliant and FDA approved.

ZaCh System is also awarded the following certifications:

  • UNI EN ISO 14001 (Environmental Management System, 2002) (Avrille)
Underpinning these achievements, our quality credentials also include:
  • QA / Regulatory Specialists to ensure that we comply with the highest international standards AFSSAPS (France), PMDA (Japan), MFDS (Korea)
  • Audits from major world wide pharmaceuticals companies