Regulatory Compliance

Regulatory Compliance – GMP/GLP

Blue Stream Laboratories maintains rigorous compliance with Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) based upon Client need.  The company also adheres to the U.S. Food and Drug Administration (FDA) guidance documents and the applicable aspects of the International Conference on Harmonization (ICH) Guidelines to maintain the highest industry standards.

Auditing History

Blue Stream Laboratories has been successfully audited by the FDA as well as by Qualified Persons (QP) for compliance with European Medicines Agency (EMA) standards.

Services Provided

Blue Stream Laboratories performs diverse analytical services to support preclinical and clinical studies.  The services include stage-appropriate method development, qualification, validation, release and stability testing for drug substance and drug product materials, and bioanalytical testing of preclinical and clinical samples.  Work is performed by expertly trained staff following customized client-approved protocols and using state-of-the-art equipment.

Quality Assurance

The Quality Assurance (QA) staff at Blue Stream Laboratories leverages its strong industry background and regulatory knowledge to ensure company-wide compliance with current, accepted industry standards and practices.  The QA team is committed to providing timely and effective collaboration with Clients and regulatory agents.

Browse our project history or contact us today to find out how we can help you.