Sebastian Clerkin


Sebastian Clerkin, Ph.D., B.Sc., is the Founder of GMP Advisory Services Ltd. and has more than 10 years experience in laboratory, pharmaceutical and medical device manufacturing environments. He currently provides validation and regulatory expertise to the Medical Device Industry. He has direct experience across a broad range of medical device types and process technologies. He has a keen understanding of FDA regulatory requirements, and has a strong background in process development, design transfer and validation.
Sebastian has published articles in peer-reviewed journals on topics such as cleaning validation.
He has a PhD from the University of Bristol, which involved studying the toxicological and biological effects of prosthetic implants. He holds a B.Sc. in Biochemistry from University College Dublin, and is a member of AAMI and ASTM.