REGULATORY STRATEGY & SUBMISSIONS
NGT works collaboratively with our clients throughout the drug development process, from late discovery through preclinical/clinical development and beyond to commercialization and life-cycle management. Our experts leverage decades of experience developing robust regulatory strategies, managing regulatory agency interactions, and authoring regulatory documentation to provide clients with the most expeditious path to approval. NGT services include the following:
- Clinical development and marketing approval strategies
- Due diligence assessments and gap analyses
- Regulatory submission project management
- Development, review, and/or submission of:
- Investigational applications (e.g., IND, CTA, IMPD, Investigator Brochure)
- Marketing applications (e.g., NDA, ANDA, BLA, MAA)
- Annual reports
- Amendments, supplements, and variations
- Drug Master Files (DMF)
- Responses to agency questions
- Requests for special regulatory development and marketing approval programs/designations
- eCTD publishing and submission (US, EU)
- Regulatory agency liaison responsibilities including:
- Management of agency interactions
- Preparing meeting requests and briefing packages
- Leadership and participation at agency and related meetings (e.g., pre-IND, Type A/B/C, advisory committee)
- Pre-approval submission and inspection readiness assessments
- Regulatory agency submission response strategy
- Regulatory intelligence monitoring
CASE STUDY – Rare Disease Regulatory Strategy
Situation
A pharmaceutical client acquired an asset with considerable Phase 2b data supporting a cardiovascular indication. The company wished to repurpose the chemical entity to treat a rare disease and required regulatory and clinical support to submit a type B meeting request to the FDA.
Solution
NGT consultants analyzed the cardiovascular clinical study reports, disease history, public domain literature, and other related internal documents. NGT consultants subsequently developed a Product Development Plan that included a 505(b)(2) roadmap and a financially viable clinical program for the rare disease indication.
Impact
The proposed strategies provided the client with the most expeditious registration and market access pathways enabling compressed timelines and manageable budgetary options.
