REGULATORY STRATEGY & SUBMISSIONS
- Comprehensive product development and marketing approval
- Due-diligence and gap analyses
- Regulatory agency liaison responsibilities including management of agency interactions
- eCTD ready documentation development, review and submission
- Pre-IND and other Type A, B an C meeting leadership and participation
- Investigational applications, annual reports and amendments
- Marketing applications including requests for expedited designations
- Requests for special regulatory development and marketing approval programs/designations
- Pre-Approval Inspection readiness assessment
For further information regarding our Regulatory Strategy & Submissions
Please contact:
Michael K. O’Brien, PhD | 860-207-8135
[email protected]
CASE STUDY – Rare Disease Regulatory Strategy
Situation
An early stage pharmaceutical client acquired an asset with Phase 2B cardiovascular data and a goal to repurpose the drug for a rare disease indication. The client required regulatory and clinical expertise to support a type B meeting request with the FDA.
Solution
NGT consultants, through analysis of the cardiovascular clinical study reports, provided feedback on the feasibility of applying the CV data to the therapeutic area of interest. Our regulatory strategist developed a roadmap for the rare disease indication.
Impact
First-line regulatory strategy was created. A product development plan was developed that redirected the effort towards a viable rare disease regulatory pathway.
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