CMCRegAff, LLC Information

CMCRegAff, LLC provides senior level, strategic Chemistry, Manufacturing and Controls (CMC) regulatory sciences consulting services for Pharma and Biopharma companies. Our extensive experience in the global pharmaceutical industry provides insights and a comprehensive understanding of the CMC regulatory review and approval process. You can trust CMCRegAff, LLC for your CMC requirements. CMCRegAff, LLC 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 Active Pharmaceutical Ingredients (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