GDUFA: FDA adds further weight to modelling and simulation’s role in bioequivalence
GDUFA 2026: FDA strengthens role of modeling & simulation for inhaled generic drug bioequivalence. Learn how this shift enhances efficiency for OINDP development.
Optimizing OINDP Regulatory Paths With Model Master Files (MMF)
Streamline OINDP regulatory submissions with Model Master Files—confidential, reusable models that accelerate drug development and U.S. FDA review.
SmartTrack™ Brochure
Discover SmartTrack™, an alternate path to FDA approval for orally inhaled and nasal drug products.
