Compliance & certification
Regulatory Management
Avantor is fully committed to complying with the regulatory requirements in every region in which we operate.
We serve industries subject to rigorous quality, performance and reliability regulations. Product quality is assured by our quality systems, beginning with an effective design protocol and continuing up the supply chain, from vendor qualification through product distribution.
We have filed — and maintain — approximately 785 master access files (“MAF”) and drug master files (“DMF”) that are registered with regulatory authorities globally. These important files provide critical information about our products to regulatory authorities and customers around the globe.
ISO Certifications
Avantor is proud to hold certification in the following ISO Standards:
- Quality: ISO 9001:2015 and ISO 13485
- Environment: ISO 14001:2015
- Health and Safety: OHSAS 18001:2007 and ISO 45001:2018
Demonstrating this commitment to standards certifications, our customer fulfillment center in Bridgeport, NJ was our first location to achieve ISO 9001 certification in 1995, for its Quality Management System. Over time, the scope was extended to Distribution and Service Centers throughout North America including Canada and Puerto Rico.
Our ISO 9001 Certifications help us meet and exceed our customer expectations:
cGMP MANUFACTURING & cGDP DISTRIBUTION
Our global footprint and capabilities include thirteen cGMP facilities and nineteen ISO-certified distribution facilities, creating a manufacturing and distribution network that is designed to meet stringent Quality & Regulatory requirements and standards. We offer more products under relevant cGMPs as part of our manufacturing strategy.