Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, and PV quality systems.
We will take you all the way through to compliance following a high quality compliance audit.
Our regulatory affairs professionals have years of experience working with the FDA throughout the pharmaceutical, medical device/diagnostic industries.
Choose from our selection of former FDA & industry experts to find qualified expert witnesses for your case.
While an inspection may seem like a distant concern, class II and class III manufacturers are technically subject to one at least every two years. FDA’s regulations for quality systems––FDA 21 CFR...Continue Reading
The FDA Group Ranks #3 on Boston Business Journal's "FAST50" List with 892.78% growth from 2012 to 2015. WESTBOROUGH, MA, May 18, 2016 -- The Boston Business Journal recently ranked The...Continue Reading