Service 02 / 07 · Non-CMC Regulatory
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.
Scope of the Non-CMC regulatory practice
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
Distinct discipline
CMC is a separate discipline from non-CMC regulatory strategy. NGT staffs each independently and coordinates them where a program needs both. See CMC Consulting →
Relevant leadership
Backed by NGT's network of more than 200 consultants across every development discipline.
Reference
Frequently asked questions
What is regulatory strategy and submissions consulting?
It is the non-CMC regulatory discipline that plans how a program will move through health authorities and authors the submissions that carry it there, including IND and CTA filings and NDA, BLA, and MAA dossiers.
What is a 505(b)(2) pathway?
505(b)(2) is a US regulatory pathway for a new drug application that relies in part on data the applicant did not generate itself, such as published literature or a previous finding of safety and effectiveness. It can offer a more direct route for certain candidates.
What does a US Agent do?
A US Agent is the required in-country point of contact for a foreign company that interacts with the US health authority. The agent receives communications and helps coordinate the sponsor's dealings with the agency.
How do CMC and non-CMC regulatory consulting differ?
Non-CMC regulatory covers clinical, nonclinical, and administrative strategy and the authoring of those submission sections. CMC regulatory covers the manufacturing and analytical content. NGT runs them as separate but coordinated practices.
Bring NGT into your program
Tell us where your program stands and which disciplines you need. A member of the team will follow up.