Chemistry, Manufacturing & Controls – NGT BioPharma Consultants

Chemistry, Manufacturing & Controls (CMC)

CMC includes several interrelated disciplines that are critical to ensuring the quality, safety, and efficacy of drug substance and products through rigorous oversight of their composition, manufacturing processes, and regulatory compliance, enabling consistent biologic and small molecule scalability, production, 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:

Early-Stage Development

Pharmaceutical “developability” assessment and optimization of lead compounds
Physico-chemical characterization of new chemical entities (NCEs)
Pharmaceutical development strategy (API, analytical, drug product, clinical supply)
Analytical methods development
Ensure Quality Target Product Profile achieves desired Target Product Profile
CMC information for IND/CTA and European IMPD applications
Select and/or qualify CDMO’s and CRO’s; coordinate and provide oversight

Late-Stage Development

Pharmaceutical development strategy for pivotal clinical studies and commercial manufacturing
Select and/or qualify CDMO’s and CRO’s; coordinate and provide oversight
Clinical supplies for pivotal studies, including strategies for using comparator drugs
Commercial API synthesis, formulation, and process development
Analytical control strategies for commercial product, storage conditions, and shelf life
Scale-up and building of commercial supply chain; achieving launch readiness
CMC information for NDA, BLA, and MAA submissions, and other regulatory submissions worldwide
Strategies for life-cycle management: cost optimizations; supporting new indications, new dosage forms and formulations