Steven Pikulin

Steven is currently the president of TechReg Services, Inc. (TRSI). He has personally written well over 100 domestic/international new drug, biologic, and generic CMC submissions for numerous healthcare companies across a wide variety of dosage forms including orally administered immediate and extended release solids, semi-solids and liquids; parenterals; nasal sprays, metered dose, and dry powder inhalation products; peptides; oligonucleotides; liquid inhalation anesthetics; pulmonary surfactants; dermal and transdermal products; medical devices; and a number of other drug therapies. His role in these projects usually involved complete management of CMC development as well as preparation of the corresponding regulatory documentation, cGMP compliance audits and interaction with the regulatory agencies. Prior to founding TRSI in 1999, he held various positions in over 20 years in the pharmaceutical industry in Drug Discovery, Manufacturing Operations, Analytical Research, Quality Control, Quality Assurance, and CMC Regulatory Affairs. He has also taught with various government, trade, and academic organizations, and has presented to the FDA and non-US regulatory agencies on CMC related topics. He has been a visiting scientist at Rutgers University, where he performs select non-GMP API and impurity syntheses under contract, and from 1998 to 2012 was an adjunct professor in the graduate Pharmaceutics/Regulatory Affairs programs at Long Island University, where he taught several courses related to pharmaceutics and regulatory affairs.