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Quality, Compliance and Regulatory Affairs


 

We foster a culture of quality and continuous improvement that not only meets the expectations of regulators and customers, but also enables business and provides a competitive advantage.

Verapharma quality organization is functionally independent from manufacturing operations, safeguarding unbiased quality decisions. In addition to local quality units, we have a global quality organization that provides governance and guidance to the local quality units, and partners with all relevant functions across the organization to foster a culture in which quality is affirmed as a business enabler and a source of competitive advantage.

Our GMP manufacturing sites operate in compliance with applicable regulations, local laws and international guidelines adopted by the various Health Authorities.

Compliance at Verapharma is continuously monitored through regulatory inspections conducted by Health Authorities, including FDA and MHRA, quality system audits conducted by our customers, as well as our internal quality audit program.

Our Quality Management Systems are designed with a GMP-phase appropriate approach to support our customers throughout the entire life cycle of their products.

Verapharma quality organization also 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.

Most recent regulatory inspections:

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

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