With 26 offices across the globe, the regulatory affairs team at Pharm-Olam International is an experienced and effective liaison for the coordination and preparation of complex multi-national submissions with all major regulatory authorities.
Pharm-Olam provides regulatory consulting as a customized stand-alone service or through our full service clinical trials. Our regulatory professionals ensure client satisfaction through streamlined procedures that provide rapid turnaround of tasks, enabling faster start up and compliance with applicable guidelines.
We can advise sponsors with strategic planning, development, evaluation, and preparation of regulatory submissions at all stages of development and post-marketing. We integrate regulatory and clinical development plans to our sponsor's pipeline strategies by performing regulatory, CMC, audits, and gap assessments to ensure submissions conform to the quality standards of regulatory authorities.
VP, Global Regulatory Affairs Sean Alan F.X. Reade
Sean Alan Reade has over 27 years of experience in the pharmaceutical industry, most recently as Director of Regulatory Affairs for PPD, Inc. and as Vice President of Regulatory Affairs at UCB/Celltech. He has also held senior regulatory positions for Maxim Pharmaceuticals, Aronex Pharmaceuticals, Boehringer Ingelheim, and SmithKline.
In his career, Sean Alan has directed the approval of over 19 NDAs [505(b)(1) and 505(b)(2)], 36 clinical SNDAs, 12 ANDAs, 1 PMA, 9 MAAs, 32 INDs, and 7 orphan designation application for branded drug products across multiple therapeutic areas for both start-ups and global pharma. Sean Alan also filed the first full eCTD ever accepted by the EMEA.
Sean Alan holds a MA in Pharmacology from Boston University School of Medicine and received advanced graduate training in pharmacokinetics at the Philadelphia College of Pharmacy and Science and in neuroendocrinology at the Massachusetts Institute of Technology.