Frontage Laboratories recently completed a successful quality audit that certifies regulatory compliance and enables 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 validates that Frontage product development, analytical testing, manufacturing facility, and quality systems are in compliance with EU GMPs. European regulations require a QP Audit to be successfully completed prior to use of clinical materials in human clinical studies within the EU. There were no major observations noted during the audit, according to Frontage.

“The completion of this successful QP Audit is an important achievement for Frontage,” said Dr. Song Li, chairman and chief executive officer of Frontage Laboratories, “While we have had solid tracking record with FDA inspections, this EU QP Audit assures us and our clients that we remain compliant with GMP regulations in both the US and EU markets.”

The QP Audit was completed Nov. 16, 2011, on behalf of a Frontage client that will soon launch EU clinical studies for a drug candidate. Earlier this year, Frontage manufactured a drug product for the client’s early stage clinical testing. After helping achieve the client’s early milestones, Frontage was asked to assist in launching the drug’s EU clinical program. The third party QP Audit recommends release of the clinical trial material for the EU study.