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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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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