Expert senior level consultation in clinical trial and post-marketing drug safety & PV including responses to Warning Letters and 483s, Data Monitoring Committees (DMCs), signal detection, change management, due diligence on new product safety, training, crisis management, interactions and strategy with FDA, EMA, MHRA & other health agencies, product safety reviews and more.
Dr. Cobert has written several books on drug safety including the standard textbook: Cobert’s Manual of Drug Safety & Pharmacovigilance now in its 2nd edition.
BLCMD Associates LLC
Barton Cobert, MD, FACP, FACG
Chapel Hill, NC 27517 USA
Tel + 1.908.251.7979