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Frederick “Simon” Golec Jr PhD RAC

CMC Regulatory Affairs Consultant

 

Dr. Frederick “Simon” Golec Jr RAC, President of CMCRegAff, LLC (founded 2010), provides senior level, strategic Chemistry, Manufacturing and Controls (CMC) regulatory sciences consulting services for Pharma and Biopharma companies. His extensive 40 years of experience in the global pharmaceutical industry provides insights and a comprehensive understanding of the scientific research, development, technology transfer and manufacturing processes of drug substances and drug products, as well as, the FDA CMC regulatory review and approval process. 

 

Dr. Golec has over 15 years (1995-2010) of experience in management, leadership and strategic positions of increasing responsibility in CMC Regulatory Sciences with major, multi-national pharmaceutical companies (Pfizer, Wyeth, Bristol-Myers Squibb and DuPont Pharmaceuticals) and Sanofi legacy companies (Rhône-Poulenc, Rhône-Poulenc Rorer). Dr. Golec was the CMC lead for regulatory approvals for New Molecular Entities (NME) and drug product dosage forms, reformulations and line extensions for medicines including TAXOTERE®, GLIADEL® Wafer, LYBREL®, CONBRIZA™, DUAVEE®, PREMARIN® and PREMPRO® several of which achieved global sales of more than $US 1 billion.

 

Dr. Golec’s early pharmaceutical career of over 18 years (1977-1995) provided an extensive involvement in, and understanding of, Active Pharmaceutical Ingredient (API) Drug Substance Manufacturing Sciences in scientific, technology, management and leadership positions in Chemical Process Research and Development of API Drug Substance with Sanofi legacy companies (Rhône-Poulenc Rorer, Rorer Group, Revlon Health Care Group, and Revlon).

 

Dr. Golec’s subject matter expertise includes: 

Advising on Investigational New Drug (IND) Applications, Drug Master Files (DMF) and New Drug Applications (NDA) Regulations and Requirements related to API Drug Substances and Dosage Forms CMC regulatory strategy, critical review and assessment, related to the content of the Drug Substance (semi-synthetic, synthetic, natural product, peptide) and Drug Product dosage form (tablet, capsule, wafer, patch, solution, injectable) Quality modules (Module 2: Quality Overall Summary (QOS) and Module 3: Quality) of the Common Technical Document (CTD) Interpretation and Application of CMC Regulations and Guidances for NDA and DMF for Post-Approval Life Cycle Management Conformance and Compliance Strategic Advice on the Interpretation and Application of CMC Guidances and CMC Regulations and Establishment of CMC Case Study Precedence CMC Regulatory Strategy Development and Implementation Inclusive of Quality, Safety and Efficacy Interconnections CMC Regulatory Gap Analysis for Identification, Assessment and Provision of Mitigation or Remediation Strategies for Conformance and Compliance CMC Regulatory Planning, Preparation and Participation in FDA Meetings CMC Regulatory Problem Solving Related to Drug Substance, Drug Product, Dosage Form, Contract Development and Manufacturing Organizations (CDMOs) or Technology Transfer CMC Regulatory Sciences Due Diligence for Assessment, Analysis, Summary and Recommendations for Startups, Joint Ventures, Acquisitions or Business Partnerships

 

 

 

 

 

Contact Info:

Company:
CMCRegAff, LLC
416 Baird Road

Merion Station, PA 19066

Cel: 610-731-4452

Email: golec@CMCRegAff.com or simong1326@gmail.com

Web: www.CMCRegAff.com

Web: www.linkedin.com/in/cmcregaff

 

Good Company! Good Drink! Good Food! Good Program! Good Fun!

 

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