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.

Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world.