Compliance & Certification

Regulatory Management

Our Regulatory Affairs Department has expertise in a wide array of regulatory domains relevant to the life sciences industry. They routinely interact with regulatory organizations and authorities throughout the world and ensure Avantor has the right to conduct business involving regulated products, thereby supporting a reliable supply chain that can be trusted by our customers and others. 

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 to product distribution and post-market support.

We have filed and maintain close to 800 master access files (“MAF”) and drug master files (“DMF”) that are registered with regulatory authorities globally— helping to simplify medical and pharmaceutical product approval processes by allowing manufacturers to reference our products as part of their own applications.

ISO Certifications

Our management systems, manufacturing processes, services and documentation procedures are designed to fulfill the requirements of our various certifications and regulatory approvals. Our Global Quality Management System is scalable to create a consistent customer experience in the different markets we operate.

We are proud to hold current certifications in the following ISO Standards:

• Quality: ISO 9001 and ISO 13485
• Environment: ISO 14001
• Health & Safety: ISO 45001

Read our full list of ISO 9001 Certifications helping us meet and exceed customer expectations.

Our cGMP facilities and ISO-certified manufacturing and distribution facilities create a manufacturing and distribution network that is designed to meet stringent Quality and Regulatory requirements and standards.