Chemistry, Manufacturing & Controls (API and Drug Product)

NGT BioPharma Consultants’ Chemistry, Manufacturing & Controls (CMC) services support both small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy as well as new modalities), API, analytical, and drug product disciplines while recognizing that their relevance varies depending on a project’s stage of development. Our experience and expertise can be applied as early as late-stage discovery and spans preclinical and clinical drug development, registration, commercialization, and life-cycle management. NGT’s CMC efforts, which closely align with Nonclinical, Clinical, Regulatory, and Quality/Compliance activities, include but are not limited to the following:

EARLY-STAGE DEVELOPMENT

LATE-STAGE DEVELOPMENT

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.

Daniel-Schaufelberger

For more information
please contact:

Daniel Schaufelberger

860.333.9023 ext. 403

OR Contact:

Rachel Franckowiak

Senior Director, Administration