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