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Frederick G. | Elance
 
176985602337900
Last Sign-in: Mar 19, 2015

Frederick G.

Senior Consultant Chemistry Manufacturing Controls
   United States
  |   Merion Station, PA

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Overview

I provide senior level, strategic Chemistry, Manufacturing and Controls (CMC) Regulatory Sciences consulting services to Pharmaceutical and Biopharmaceutical companies, Contract Research Organizations (CRO) or Contract Manufacturing Organizations (CMO) on drug substance and drug product at all phases of the Investigational New Drug (IND) development, the New Drug Application (NDA) planning and submission to approval and for the maintenance of NDA Post-Approval, Life Cycle, regulatory CMC Compliance and Conformance. I am a subject matter...

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Portfolio

Senior Consultant Chemistry Manufacturing Controls CMC Regulatory Sciences

Skills (7)

Tested
chemistry manufacturing controls cmc regulatory affairs
consultant
reviewer
pharmaceutical
FDA

Service Description

CMCRegAff, LLC expertly advises Pharmaceutical and Biopharmaceutical companies in the following areas:
*CMC regulatory strategy, critical review and assessment, related to the content of the Drug Substance / Active Pharmaceutical Ingredient (API) (synthetic or semi-synthetic small molecule, natural product, fermentation product, synthetic peptide) and Drug Product Dosage Form (tablet, capsule, patch, cream, wafer, solution, injectable) Quality modules (Module 2: Quality Overall Summary (QOS) and Module 3: Quality) of the Common Technical Document (CTD) for regulatory submissions
*Interpretation and Application of CMC Regulatory Regulations and Guidances for Investigational New Drugs (IND), New Drug Applications (NDA), and Drug Master Files (DMF)
*Strategic Advice on the Interpretation and Application of CMC Regulatory Guidances, Legal Requirements of 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 CMC Regulatory Mitigation Strategies for Remediation
*Mitigation Strategies for CMC Regulatory Conformance and Compliance
*CMC Regulatory Planning, Preparation and Participation for FDA (Food and Drug Administration) or European Medicines Agency (EMA) Meetings
*CMC Regulatory Problem Solving Related to Active Pharmaceutical Ingredient (API), Drug Product Dosage Form, Contract...

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Employment

CMCRegAff, LLC
President
2010 - Present
Provide senior level, strategic CMC Regulatory Sciences consulting services to Pharmaceutical and Biopharmaceutical companies, Contract Research Organizations (CRO) or Contract Manufacturing...
Pfizer / Wyeth
Senior Director Global Regulatory Affairs CMC
2002 - 2010

Education

University of Washington, Seattle, Washington
PhD
1973 - 1978
Overview  |  Job History  |  Portfolio  |  Resume/C.V.

Keywords

regulatory consultant
pharmaceutical
cmc
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simong1326
Type
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Member Since
February 2015
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Frederick G. | Elance

Frederick G.