Frederick “Simon” Golec Jr., PhD, RAC—API and Drug Product CMC Regulatory Strategist

More than 40 years experience as a leader and executive in drug product CMC regulatory sciences

An analytical and circumspective problem solver, Dr. Golec is highly regarded for his API and drug product knowledge, business agility, regulatory expertise and experience interacting with CROs, CDMOs and CMOs. His knowledge and experiences in chemical process R&D and CMC regulatory science, combined with his expertise in gap analysis and risk assessment, helps companies improve risk-based decisions and risk management. Dr. Golec also advises entrepreneurs and investors in CMC regulatory de-risking of technology to develop the highest probability of success consistent with funding, business plans and exit strategies, and due-diligence assessments related to investment, in-licensing and out-licensing. He is adept at engaging and integrating multidisciplinary teams to provide adaptive—yet actionable—CMC strategies for regulatory approval of NMEs, and advises small molecule biopharma companies throughout all stages of CMC drug development, including regulatory review processes, submissions, approvals and Post-Approval Life Cycle Management Compliance (P-ALCMC).

Dr. Golec’s extensive background includes President and Founder of CMCRegAff, LLC and Sr. Director of Global Regulatory Affairs/CMC at Pfizer (Wyeth legacy company). He provided CMC leadership for numerous regulatory approvals for NMEs and drug product dosage form reformulations and line extensions, developed CMC regulatory strategies, provided critical reviews and assessments of API and drug product regulatory submission content of Module 2: Quality Overall Summary (QOS) and Module 3: Quality; CMC strategy for regulatory Agency meetings on API issues for Quality by Design (QbD), Comparability Protocols, bridging strategies and assessment, control and qualification strategies for impurities, critical assessments and solutions for strategic CMC issues related to API CMO, CDMO or CRO selection and Quality Agreements. He additionally served on a variety of API regulatory initiative work groups, including on the Analytical Technical Group (ATG) sub-team on genotoxic impurities, as a support team member for the Expert Working Group (EWG) on development of ICH Q11 guidance, and on the Process Quality Research Institute (PQRI) Genotoxic Impurities (GI) Work Group.

Expertise 

• Comprehensive API and drug product CMC regulatory sciences, including guidelines, agency policies, procedures and practices, case studies 
• Strategic development of chemical, pharmaceutical, analytical and CMC regulatory plans
• CMC regulatory project management for agency meetings, submissions, review and approval processes