James Knox

Knox has over 30 years of FDA regulatory affairs expertise. In the last 20 years, he is considered by many to be the top device regulatory affairs expert, having worked on projects for Genzyme, Novartis, and GSK. He has experience in direct negotiations with the FDA and helping formulate project team strategies, US and EU pre- and post-approval projects, like CTA applications. His work includes pre-clinical and clinical program design, clinical trial monitoring, clinical auditing, adverse event evaluation and reporting, new and existing facility compliance auditing, drug substance and drug product manufacturing, CMC activities from pilot work through full-scale production and post-approval product changes, microbiology, quality assurance, training, scientific affairs, drug and device regulatory affairs, publications, labeling and package inserts, and a wide range of other clinical and regulatory functions to assure compliance with US, EU and some Japanese regulations. He is an expert in performing labeling due diligence and subsequent data remediation.