We understand the importance of compliance and can help guide your analytical program through the expectations of regulatory agencies and GMP compliance. We proactively share troubleshooting approaches, analytical investigations, and tracking and trending data while collaborating with you through manufacturing investigations to help achieve the best scientific and regulatory outcomes.
Our Quality Assurance (QA) team is staffed with seasoned professionals with many years of biopharma analytical laboratory experience and comprehensive knowledge of phase-appropriate GMP.
GMP testing is subject to a harmonized quality management system across our three sites in the U.S. and U.K.
An independent global GMP QA team, with an average individual tenure of over 10 years, provides oversight to effectively support quality, safety and reliability
Our global quality management system has been subject to regular regulatory review from the Food and Drug Administration, European Medicines Agency, Medicines and Healthcare products Regulatory Agency and several other global regulatory authorities with an outstanding level of success
