January 18, 2012 -- Frontage Laboratories, Inc., a global pharmaceutical contract research organization (CRO), today celebrated another achievement in quality by meeting FDA standards for testing commercial products in its Chemistry, Manufacturing and Controls (CMC) labs for the fourth time in four years.
The company hosted an FDA inspector who completed the annual review of CMC Quality and Lab Systems with no Form 483 citations. As a result, the Exton, PA, facilities maintain certification as commercial testing labs.
“We make it a priority to build in quality from start to finish for every project,” said Song Li, PhD, Frontage Founder and CEO. “This compliance certification from FDA is continued proof that our quality systems are working and it gives added confidence to our current and new clients.”
The Frontage CMC division provides services in the areas of pharmaceutical API development and GMP manufacturing, analytical testing, formulation product development and manufacturing of clinical trial materials including Sterile (Injections and ophthalmic), Oral Solid (IR and CR), Topical, and High Potent products.
US Quality Certification Follows Similar Approval by EU Inspectors
This new FDA stamp of approval follows another recent quality achievement by Frontage. In November, the company completed a successful quality audit that certified regulatory compliance and enabled it to provide clinical trial materials for a client’s upcoming European Union (EU) clinical study.
Known as a Qualified Person (QP) Audit, the process validated that Frontage product development, analytical testing, manufacturing facilities, and quality systems are in compliance with EU Good Manufacturing Practices (GMPs). Just as in today’s FDA audit, there were no major observations noted by the QP inspector.
Frontage Laboratories, Inc. is a global contract research, development and manufacturing organization, offering a full range of pharmaceutical R&D services. Frontage operates in the US and China, using one seamless GXP platform. Frontage runs three Phase 1 Clinical units, a 72-bed Phase 1 Unit in Hackensack, NJ, a 120-bed Phase 1 Unit in Zhengzhou, Henan Province China, and a-80 bed Phase 1 Unit in Changchun, Jiling Province China. Frontage has an AALAC certified preclinical animal facility in Pennsylvania, where it also maintains bioanalytical and CMC facilities. In Shanghai and Beijing, China, the company also operates bioanalytical and CMC facilities. As a rapidly expanding CRO with ten years of success providing high-quality GXP services, Frontage has established an international standard in pharmaceutical product research, development, quality and management systems.