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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 Lonigo plant has never received a Form 483 in over 20 years of operation. Last audit (no 483) performed in 2010.
• 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. Last audit (no 483) performed in 2010.

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, 2003) (Avrille and Lonigo facilities)
• OHSAS 18001 (Safety Management System, 2004) (Lonigo facility)

Underpinning these achievements, our quality credentials also include:

• QA / Regulatory Specialists to ensure that we comply with the highest international standards AIFA (Italy), AFSSAPS (France), PMDA (Japan), KFDA (Korea)
• Audits from major world wide pharmaceuticals companies