The award, shared in the special Quality Assurance Edition (May 2022) of Pharma Tech Outlook Europe magazine, lists the top ten companies providing the best Quality Assurance services for the pharmaceutical industry. AGC Biologics is the only CDMO to be included in this year’s Top 10 Quality company list.
Pharma Tech Outlook is a leading global industry news source pioneering real-world solutions, news, product trends, and other important topics related to the pharmaceutical industry. The publication uses a collaborative, peer-driven approach to address the important needs of the industry. The magazine highlights leaders, innovative companies and important news impacting the pharmaceutical space.
“We are honored to accept the award as one of the Top 10 Quality Assurance Services Companies in our industry. As a company, we lead with quality and safety, and truly believe that quality is the responsibility of every individual at AGC Biologics,” said Paul Tsang, Executive Vice President of Global Quality, AGC Biologics. “I’m humbled to help guide the direction of our global team that cares deeply for our customers and their patients. This honor is a true testament to the hard work, dedication and work of everyone within the Global Quality organization.”
“Our integrated Quality Management System combined with our cGMP expertise helps us support our clients in not only performing in-process, intermediate, and final product testing, but also offer them faster time-to-market and improved success rate by building quality into products and processes,” notes Tina Guldberg, Vice President of Quality, AGC Biologics Copenhagen.
AGC Biologics offers an integrated quality management system (QMS), which incorporates requirements from the US, EU, Japan, and other major compliance and regulatory guidelines (e.g., ICH, PhEur, USP). The company’s facilities have been inspected by the Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA).
AGC Biologics is currently expanding at several facilities across the globe to grow quality and other important services, including at three sites in Europe in Copenhagen, Denmark, Heidelberg, Germany and Milan, Italy. These expansions support the company’s mission of furthering quality standards for pharmaceutical products it helps bring to market. In Copenhagen specifically, the company is building an additional facility that adds 8,000 square meters of space to the current mammalian and microbial biologics site. The new expansion includes state-of-the-art mammalian manufacturing capabilities, additional technical and warehouse space, and new quality control laboratories that will help the company continue to innovate its quality and regulatory services.
To learn more about AGC Biologics’ quality assurance, quality control and regulatory services, visit www.agcbio.com/capabilities/quality-regulatory.