Nanopharm-logo-with-signature-Pantone (1)
Close this search box.

OINDP Alternative Bioequivalence – Regulatory Support

Alternative bioequivalence pathways have already been established for a number of conventional dosage forms. However, the complexity of OINDP product development brings bigger challenges in this regard. Nanopharm’s dedication to advancing inhaled and nasal drug product development has resulted in the creation of an alternative pathway to bioequivalence for OINDPs that can meet today’s regulatory requirements. Our SmartTrack™ platform provides an in-vitro and in-silico based approach to comparative bioequivalence for inhaled drug products.

OINDP Alternative Bioequivalence Regulatory Support

As a pioneer in the creation of new alternative non-clinical pathways to bioequivalence for OINDPs, Nanopharm is able to provide the regulatory support needed to accompany customers through this newly established approach. Nanopharm designs alternative pathway development programs that can be acceptable to regulators and meet their data and documentation requirements. We can therefore help guide our customers through regulatory body reviews that involve the use of our new in-vitro in-silico bioequivalence approaches.

Nanopharm applies its specialized expertise to create alternative pathways to comparative bioequivalence. With unrivalled regulatory support, Nanopharm leads the way for alternative bioequivalence for OINDPs.

While Nanopharm was innovating new alternative bioequivalence platforms, it collaborated closely with the U.S. FDA, enabling it to provide unmatched regulatory support for customer OINDP projects.

Innovating an Alternative Pathway to Bioequivalence

Nanopharm is a leader in charting new alternative pathways to bioequivalence waivers for inhaled drug products using its SmartTrack™ platform. Our scientists have created a multidimensional development approach that includes the use of innovative in-vitro and in-silico modeling enabling customers to eliminate, the costly and time consuming Comparative Clinical Endpoint (CCEP) studies that are normally required to demonstrate bioequivalence for repositioned or new inhaled drug products. Our proprietary SmartTrack™ platform can save companies millions of dollars and years of clinical study time in the development of their OINDP, replacing Bioequivalence studies with a more robust and representative alternative pathway. 

SmartTrack™ was made possible because of Nanopharm’s commitment to providing innovative OINDP development services. As regulations are a critical consideration for any new alternative pathway to product approvals, Nanopharm has consistently collaborated with major regulatory bodies, such as the U.S. FDA, to ensure the new approach complies with the necessary regulatory requirements.  We can guide and support our customers step by step through the alternative pathway process with unique regulatory support. From the earliest stages of development to regulatory submissions, dossier development, and filings, Nanopharm offers expert regulatory support to advance OINPs via alternative regulatory pathways. We are uniquely positioned to provide guidance and technologies to exploit this novel approach for inhaled drug products, which were developed over many years of collaboration with U.S. FDA.

Working With Major Regulators

Whether navigating traditional regulatory pathways or exploring innovative approaches to generic bioequivalence, Nanopharm provides specialized regulatory support to client projects. Recognized as innovators in designing alternative pathways that demonstrate bioequivalence of OINDP generic drug products to the test article, we possess unparalleled knowledge and expertise on the subject. 

We recognize the importance of earning credible endorsements from leading regulatory bodies for this new approach; without their approval, innovations such as SmartTrack™ and other alternative bioequivalence methods would not be useful in securing regulatory approvals.

Years ago, we initiated a cooperative collaboration with the U.S. FDA during the early stages of our alternative bioequivalence platform development.

This collaboration aimed to refine our comparative bioequivalence platform and earn acceptance for this novel approach applied to the practical development of OINDPs. 

Our regulatory consultancy offers this unique perspective and expertise to all applicable client projects, encompassing direct support and involvement in client-regulator meetings.

As global pioneers in developing and introducing SmartTrack™ and other alternative bioequivalence processes, we offer unparalleled regulatory support to our clients in the field of OINDP development.

Nanopharm OINDP Specialists for Alternative Bioequivalence

As pioneers in creating an in-silico and in-vitro based pathway, Nanopharm has the ability to offer some of the most comprehensive and informed regulatory support available anywhere OINDP development by this approach. Trust your next nasal or inhaled drug product development process to the regulatory experts at Nanopharm, an integral part of our alternative bioequivalence development programs.