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