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:
CASE STUDY – Rare Disease Regulatory Strategy
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.
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.
The proposed strategies provided the client with the most expeditious registration and market access pathways enabling compressed timelines and manageable budgetary options.