Our Business

GMQA approaches each project with passion and personalized attention to detail.  We enjoy challenges and the thrill of helping you successfully integrate people, processes, technologies, and quality systems to do what you strive to do best:  discover, test, manufacture, distribute, and continue to assure the on-going safety of the highest quality pharmaceuticals, biologics, medical devices, and combination products. GMQA's ultimate goal is to help you protect patient safety, product quality, and assure data integrity.

Monica J. Cahilly, M.S., President, GMQA, LLC, has 20+ years consulting experience with specialized interest (and enthusiasm) for Assuring Data Integrity, Pharmacogenomics Laboratory Compliance, Computer Systems Validation (CSV) and 21 CFR Part 11 Compliance, Information Technology / Information Services Quality & Compliance, Bioanalytical / Toxicology Laboratory Compliance, and general Quality Systems, and has worked with domestic and international companies regulated by FDA GMP / GLP / GCP / QS Reg, VICH, OECD / EPA GLP, as well as university and R&D settings. Monica is a frequent lecturer and author of several articles / book chapter / newsletters. Monica holds a B.A. Biochemistry from Dartmouth College, a M.S. Genetic Toxicology from M.I.T., is a member of PDA, ISPE, SQA, NERCSQA, DIA and is a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP).

Click here for a link to Monica's current cv.

Hear what others said about recent training by GMQA...

 "Monica's knowledge of the material was fantastic. She explained complex material with excellent clarity. But the best part of her presentation was her enthusiasm keeping everyone engaged -- no mean feat."

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"One of the best (if not THE best) I've attended. I've attended lots on the subject."

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"Very good speaker -- knows subject at expert level. Very realistic and pragmatic approach."

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 For more information on GMQA consulting services, please contact us.   ** If your needs extend outside our current areas of expertise or staffing, we would be happy to recommend highly-qualified consultants through our personal network of respected friends and colleagues.