CMCRegAff, LLC

The Regulatory Expertise Your Project Needs

Trusted Pharmaceutical Industry Insight

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Strategic Chemistry, Manufacturing and Controls (CMC) Regulatory Sciences Consulting Services

Consulting Services

Having a prospective, robust and adaptive CMC Regulatory Strategy is essential when dealing with Regulatory Agency (FDA, EMA) interactions or Meetings, Submissions, Conformance or Compliance. CMCRegAff, LLC provides expert CMC Regulatory Consulting Services to assure that Investigational or Approved, Marketed Pharmaceutical Products adhere to Regulations and Agency standards.

Conceptual Image of Solutions Letters on Question Mark Background

Strategic Chemistry, Manufacturing and Controls (CMC) Regulatory Sciences Consulting Services

Consulting Services

Having a prospective, robust and adaptive CMC Regulatory Strategy is essential when dealing with Regulatory Agency (FDA, EMA) interactions or Meetings, Submissions, Conformance or Compliance. CMCRegAff, LLC provides expert CMC Regulatory Consulting Services to assure that Investigational or Approved, Marketed Pharmaceutical Products adhere to Regulations and Agency standards.

Dr. Frederick “Simon” Golec, Jr., RAC

Few CMC Regulatory Consultants in the pharmaceutical Research and Development field are as knowledgeable or experienced as Dr. Golec. He has extensive and direct experience working within all aspects of pharmaceutical Regulation, due Diligence, Research, Development, Technology Transfer, Commercialization and Life Cycle Conformance and Compliance.

Contact Dr. Golec to learn more about CMCRegAff, LLC CMC Consulting Services.

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Call (610) 731-4452 to request CMC Regulatory Consulting Services via phone, Microsoft Teams or Zoom.

About Us

CMCRegAff, LLC provides executive-level strategic CMC Regulatory sciences Consulting Services for Pharma and Biopharma companies regarding Agency (FDA, EMA) Regulations and requirements for the US and Europe. With more than 40 years of experience in the global pharmaceutical industry CMCRegAff, LLC provides you with a leading-edge advantage, as well as a comprehensive understanding of the CMC Regulatory process.
From the CMC Regulatory requirements for Investigational Clinical Trials to New Drug Applications and Marketing Authorization Applications to Post-Approval Life Cycle Management of Regulatory Conformance and Compliance, CMCRegAff, LLC are experts in the pharmaceutical industry. You can trust CMCRegAff, LLC to be as detailed as necessary when working with you, no matter what the capacity.

CMCRegAff, LLC will work with Pharma or Biopharma companies or Contract Manufacturing Organizations (CMOs) and Contract Manufacturing and Development Organizations (CDMOs) to provide CMC Regulatory Review and Risk Assessment and advise on the client’s project to develop an actionable Regulatory Strategy that provides prioritized cost-effectiveness for the client with maximum Return On Investment (ROI).