CMCRegAff, LLC

CMCRegAff, LLC is a Chemistry, Manufacturing and Controls (CMC) Regulatory sciences Consulting company with exceptional and unique expertise in CMC Regulations and requirements for Regulatory approval.

Whether you are planning for Clinical Trials, conducting Investigational or Pivotal Clinical Trials, planning or preparing to submit a New Drug Application (NDA) or Marketing Authorization Application (MAA), have an NDA or MAA under review or are seeking approval or managing Post-Approval Life Cycle Management Control of Change for an Approved, Marketed New Molecular Entity (NME), CMCRegAff, LLC will expertly assist you at all stages of the CMC Regulatory process to maintain Regulatory Conformance and Compliance.

Expert Consulting

You need to be assured that you have a qualified, senior-level, subject matter expert CMC Regulatory sciences Consultant on your team when developing and seeking approval for new Pharmaceutical Products. CMCRegAff, LLC has the proven scientific, technical and CMC Regulatory expertise, knowledge, experience and skills that you require for new medicines and biopharmaceutical products. CMCRegAff, LLC Consulting Services will work with you to provide expert strategic advice and guidance 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, 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 Manufacturing Organization (CMO) or Technology Transfer
CMC Regulatory Sciences Due Diligence for Assessment, Analysis, Summary and Recommendations for Potential Startups, Joint Ventures, Acquisitions or Business Partnerships

Contact CMCRegAff, LLC to speak with us regarding our CMC Regulatory Sciences Consulting Services.