Compliance & certification
Avantor is fully committed to complying with the regulatory requirements in every region in which we operate.
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 product distribution.
We have filed and maintain over 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 support our various certifications and regulatory approvals, bolstering our efforts to meet all requirements for global standardization and quality assurance.
We are proud to hold certification in the following ISO Standards:
- Quality: ISO 9001:2015 and ISO 13485
- Environment: ISO 14001
- Health & Safety: ISO 45001
Underpinning our commitment to offering the highest level of quality and safety in our processes, we successfully completed our ISO certification audit cycle for our European Integrated Management System with zero non-conformities across the network. The audit’s scale included 21 days of onsite evaluation to complete our Integrated Management System focusing on ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018. This triple recertification is an example of Avantor’s commitment to uphold industry best practices in quality and safety.
Read our full list of ISO 9001 Certifications helping us meet and exceed customer expectations.
Our 13 cGMP facilities and 34 ISO-certified distribution facilities create a manufacturing and distribution network that is designed to meet stringent Quality and Regulatory requirements and standards.