NGT BioPharma Consultants’ Chemistry, Manufacturing & Controls (CMC) services support both small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy, and other new modalities), API, analytical, and drug product disciplines while recognizing that their relevance varies depending on a project’s stage of development.
Our broad capabilities and expertise can be applied as early as late-stage discovery and continue through preclinical and clinical drug development, registration, commercialization, and life-cycle management. Our CMC consultants also work seamlessly with other drug development functional areas, such as Nonclinical, Clinical, Quality/ Compliance, and Regulatory. NGT BioPharma Consultants’ capabilities in CMC (API and Drug Product) include, but are not limited to the services highlighted below:
Although NGT is neither a laboratory or manufacturing services provider, we can serve as your single point of contact to our network of reputable CRO’s and CDMO’s.