Service 03 / 07 · CMC
Chemistry, Manufacturing & Controls (CMC) Consulting
Chemistry, Manufacturing and Controls (CMC) consulting covers the drug substance, drug product, and analytical work required to develop, characterize, manufacture, and control a therapeutic across its lifecycle. It is a discipline distinct from non-CMC regulatory strategy, though the two work in close coordination.
A two-phase discipline, discovery to commercial supply
Early-Stage
- Developability assessment
- Physico-chemical characterization
- CMC for IND, CTA, and IMPD
- CDMO and CRO selection
Late-Stage
- Pivotal-study manufacturing
- Commercial API synthesis
- Control strategies and shelf-life
- Scale-up
- CMC for NDA, BLA, and MAA
- Lifecycle management
Distinct discipline
Non-CMC regulatory strategy is a separate discipline from CMC. NGT staffs each independently and coordinates them where a program needs both. See Regulatory Strategies & Submissions →
Relevant leadership
Backed by NGT's network of more than 200 consultants across every development discipline.
Reference
Frequently asked questions
What is CMC consulting?
CMC consulting covers the Chemistry, Manufacturing and Controls work behind a therapeutic: the drug substance, the drug product, and the analytical methods used to characterize and control them. It runs from early developability assessment through commercial manufacturing and lifecycle management.
How do CMC and non-CMC regulatory consulting differ?
Non-CMC regulatory consulting plans a program's path through health authorities and authors the clinical and administrative parts of a submission. CMC consulting owns the manufacturing and analytical content. They are distinct disciplines that coordinate closely, which is why NGT keeps CMC regulatory and non-CMC regulatory as separate practices.
When does CMC work start in a program?
CMC work starts in early development with developability assessment and physico-chemical characterization, and continues through the CMC sections of an IND, CTA, or IMPD, into pivotal manufacturing, commercial API synthesis, and lifecycle management.
What is a CDMO or CRO selection?
It is the process of choosing the contract development and manufacturing organizations and contract research organizations that will make and test material for a program. NGT helps sponsors define requirements and select partners that fit their stage and modality.
Bring NGT into your program
Tell us where your program stands and which disciplines you need. A member of the team will follow up.