Drug Development

Regulatory & Compliance Services

Commonwealth Biotechnologies, Inc. (CBI) is a fully compliant Good Laboratory Practices (cGLP) facility operating under FDA Regulations, 21 CFR 58. Some services are also offered under current Good Manufacturing Practices (cGMP) and current Good Clinical Practices (cCMP) Regulations. CBI is also CLIA certified. An overview of the Regulatory Compliance Program at CBI is available.

At CBI, compliance is the responsibility of the goal of the Quality Assurance Unit (QAU). The QAU serves as an “independent” control service for the company on its projects. It incorporates a series of checks and balances to ensure the quality of all of its laboratory services.

The QAU monitors and evaluates the effectiveness of policies and procedures for quality control, proficiency testing, and personnel competency to achieve the company’s goal of reliable and dependable analytical data. The focus of the QAU at CBI is to assure that its laboratories meet and/or exceed all regulatory agency guidelines.

CBI’s Laboratory Quality Assurance Plan focuses on factors that contribute to reliability, accuracy, precision, comparability, sensitivity, and defensibility of procedures and data produced. Goals of the Quality Assurance effort are to monitor and decrease errors and lend credibility to results.

Commonwealth Biotechnologies, Inc. 601 Biotech Drive, Richmond, VA 23235 800-735-9224 (800-RELY-CBI) FAX: 804-648-2641 email: [email protected]