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.
Optimising batch selection to increase success of PK studies for bioequivalence
Uncover Nanopharm’s SmartTrack approach for successful Pharmacokinetic and Bioequivalence studies in OINDP, using PBPK modelling.
Nanopharm’s SmartTrack: Accelerating OINDP Respiratory Drug Delivery
Revolutionize your OINDP respiratory drug delivery with Nanopharm’s SmartTrack. Accelerate development and mitigate risks through expert formulation and integrated solutions. Your pathway to success starts here.
Nanopharm: cGMP Drug Development in OINDP
Nanopharm expands with cGMP facilities for advanced drug development in OINDP. Specializing in biologics characterization and particle engineering.
Alternative regulatory path for generic Respiratory Products
Explore Nanopharm’s SmartTrack, an alternative solution for FDA approval of generic inhalation drug delivery products.
