Quality, Compliance and Regulatory Affairs

We continuously improve our Quality Management System (QMS) and its performance. Our QMS is designed with a GMP-phase-appropriate approach to support our customers throughout the entire life cycle of their products. Our goal is to be audit-ready at all times, to consistently listen to the feedback of our customers and regulators, and to exceed their expectations as a CDMO partner.

Our strict adherence to current Good Manufacturing Practices (cGMP) is reflected in the quality and reliability of our products, how we manage our people, processes and facilities, and our solid regulatory audit record. Our products and processes meet the strictest standards, and agencies health authorities worldwide, including the U.S. Food and Drug Administration (FDA) and Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., routinely audit our facilities. Rigorous quality system evaluations, including dozens of customer audits each year and our internal corporate and site quality audit programs, also provide consistent monitoring. Finally, as a manufacturer of controlled drug substances, Veranova’s facilities are routinely inspected by the U.S. Drug Enforcement Administration and the U.K. Home Office to ensure compliance with their security and control requirements.

Veranova’s quality organization includes an agile global Regulatory Affairs team. This group of highly skilled professionals supports our product portfolio growth, helps expedite the product entry to market, and maintains relationships with a large number of regulatory agencies. In doing so, they operate across the organization, partnering with multiple functions and with clients to ensure full alignment between the regulatory and business strategies and performance.

Most recent regulatory inspections:

• Edinburgh, UK: MHRA, 2021
• Devens, MA: FDA, 2019
• West Deptford: FDA, 2023