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, biotechnology, and medical device/diagnostic industries.
Choose from our selection of former FDA & industry experts to find qualified expert witnesses for your case.
Sooner or later, an FDA investigator will walk through your door, greet the receptionist and wait patiently for the...Continue Reading
When medical devices undergo changes, it leaves sponsors asking a critical question: Does the change require a new 510(k) submission? Before trying to answer that question, it’s important to...Continue Reading