Bioanalytical Quality Standards Initiative (BQSI)
The Bioanalytical Quality Standards Initiative (BQSI) is a pharmaceutical industry working group that has been organized to develop documented quality management standards for bioanalysis in support of clinical trials.
Through discussions with quality professionals in the pharmaceutical industry, Synomics Pharma identified a need for developing and maintaining specific regulations for bioanalytical testing of clinical samples as conducted either by a sponsor or contract organizations. To address this gap in clinical trials, Synomics Pharma began working with interested industry scientists and regulatory professionals to develop the Bioanalytical Quality Standards Initiative (BQSI) guideline, through collaboration with an industry working committee.
Pharmaceutical companies interested in becoming BQSI committee members can contact Dr. Kirk Smith, Senior Director of Regulatory Affairs & Quality Systems, by email at ksmith@synomicspharma.com, or by calling Synomics at 508-273-0450. Interested parties may also join the BQSI Group on LinkedIn.
