CMC are critical activities ensuring the quality, safety, and efficacy of drug substance and products through rigorous oversight of their composition, manufacturing processes, and regulatory compliance, enabling consistent production, scalability, and approval for clinical and commercial use.
NGT BioPharma Consultants’ Chemistry, Manufacturing & Controls (CMC) services supports both small molecules and biologics (e.g., mAbs, duobodies, proteins, cell/gene therapies, and other new modalities) for drug substance, drug product and analytical disciplines, recognizing that their relevance varies depending on a project’s stage of development.
Our extensive expertise and capabilities span late-stage discovery through preclinical and clinical drug development, registration, commercialization, and life-cycle management. NGT’s CMC consultants collaborate seamlessly with other key drug development functions, including our Nonclinical, Clinical, Quality/Compliance, and Regulatory teams. The CMC (API, Drug Product & Analytical) services offered by NGT BioPharma Consultants encompass, but are not limited to, the areas outlined below:
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