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Category: Topic

Targeting accelerated progress at the IPAC-RS Nasal Innovation Forum 2025

Glass front door to entrance of Nanopharm facility in the UK, with Nanopharm blue and grey wordmark and reflections.

Explore how Nanopharm presented strategies for accelerating patient-centric nasal product development at the IPAC-RS Nasal Innovation Forum 2025. Dive into key insights on regulatory science, advanced bioequivalence methods, and targeted drug delivery.

Aligning Alternative Bioequivilence with U.S. FDA: Advancing aerosol dose collection to enhance in vitro dissolution studies

Glass front door to entrance of Nanopharm facility in the UK, with Nanopharm blue and grey wordmark and reflections.

Discover how Nanopharm’s DissoHale system advances aerosol dose collection and dissolution testing to support FDA-aligned alternative bioequivalence for OIDPs.

Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques

Microstructural Characterization of Dry Powder Inhaler Formulations Using Orthogonal Analytical Techniques

GDUFA: FDA adds further weight to modelling and simulation’s role in bioequivalence

Glass front door to entrance of Nanopharm facility in the UK, with Nanopharm blue and grey wordmark and reflections.

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.

Aptar Pharma Bolsters Clinical Trial Capabilities with Strategic Materials Manufacturing Acquisition

The acquisition of Mod3 Pharma’s clinical trial materials manufacturing capabilities strengthens Aptar Pharma’s service portfolio to meet growing demand for early-phase clinical trial support and innovation

The acquisition of Mod3 Pharma’s clinical trial materials manufacturing capabilities strengthens Aptar Pharma’s service portfolio to meet growing demand for early-phase clinical trial support and innovation.

Accelerating OINDP Development with Nanopharm

Discover how Nanopharm, supports OINDP development from preclinical to CGMP with SmartTrack™, in silico modeling, and regulatory expertise.

Advancing Alternative Bioequivalence for OINDPs

Nanopharm & Fluidda explore FDA’s progress in alternative bioequivalence for OINDPs, Model Master Files (MMF), and future regulatory pathways.

In Silico Bioequivalence Beyond Generic Drug Development

Nanopharm & Fluidda discuss FDA’s in silico bioequivalence methods for alternative pathways beyond generics in inhalation drug development.

FDA’s Evolving Stance on In-Silico Studies in Bioequivalence Testing

Discover how the FDA’s evolving view on in-silico methods, with insights from Nanopharm and FLUIDDA, impacts bioequivalence and generic drugs.

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