Regulatory management

Our Regulatory Affairs Department has expertise in a wide array of regulatory domains relevant to the life sciences. They routinely interact with regulatory organizations and authorities throughout the world and ensure that 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 operate in full compliance with all relevant national and international laws and regulations, prioritizing Environment, Health, Safety, Security and Sustainability (EHSS&S), Product Information Compliance, and Quality and Regulatory Affairs. 

Through our Standards and Regulations Council (SRC), we proactively review and incorporate regulatory changes into our Quality Management System (QMS), updating our programs and standards to foster product safety, quality and legal compliance across our operations. 

We have filed and maintain over 790 master access files (MAFs) and drug master files (DMFs) that are registered with regulatory authorities globally. These files help to simplify medical and pharmaceutical product approval processes by allowing manufacturers to reference our products in their own applications.

ISO Certifications

Our management systems, manufacturing processes, services and documentation procedures are designed to support various certifications and regulatory approvals, bolstering our efforts to meet all requirements for global standardization and quality assurance.

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

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

Our good manufacturing practices (cGMP) and ISO-certified manufacturing and distribution facilities create a network designed to meet stringent quality and regulatory requirements and standards.

Learn more about our ISO 9001 certifications and quality and compliance expertise.

Read our full list of other local certifications helping us meet and exceed environmental and health and safety expectations.