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.
FDA Warning Letters and Form 483 Inspectional Observations, while not final determinations, are extremely important for companies to fully evaluate and resolve. What may seem like simple deficiencies...Continue Reading