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.
The U.S. Food and Drug Administration (FDA) issued its final guidance covering good manufacturing practice (CGMP) requirements for combination products. We've summarized the key takeaways from the...Continue Reading
Looking back on FDA’s inspectional observations issued throughout 2016, inadequate CAPA procedures topped the list at 344, followed by poor complaint handling and lack of written MDR procedures....Continue Reading