Seven disciplines, two of them deliberately kept apart
Regulatory professionals read information by structure. So NGT presents its services the way a dossier is organized: numbered, ruled, and color-coded by discipline. CMC and non-CMC regulatory are separate practices, shown side by side below rather than blended into one grid.
The two regulatory tracks
Regulatory Strategies & Submissions Consulting
Regulatory strategy and submissions consulting is the non-CMC regulatory discipline that plans a program's path through health authorities and authors the submissions that carry it there. It spans IND and CTA filings, NDA, BLA, and MAA dossier authoring, expedited program requests, designations, and direct agency interaction.
Submissions
- IND and CTA submissions
- NDA, BLA, and MAA dossier authoring
- Emergency Use Authorization (EUA) submissions
Expedited Programs
- Breakthrough Therapy requests
- Fast Track requests
- Priority Review requests
- Accelerated Approval requests
Designations & Special Pathways
- Orphan Drug Designation
- Special Protocol Assessments (SPA)
- Rare pediatric disease guidance
Agency Interaction
- Pre-NDA meeting preparation
- Health authority responses
- US Agent services
Diligence
- Regulatory due diligence and gap analysis
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.
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
Note CMC and non-CMC regulatory are distinct disciplines. NGT staffs and runs them separately, and coordinates them on programs that need both.
Development & Operations disciplines
Bring NGT into your program
Tell us where your program stands and which disciplines you need. A member of the team will follow up.