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OINDP Regulatory Consultancy Services

OINDP Regulatory Consultancy Services

Not only does Nanopharm offer advanced intranasal and inhaled drug product development and testing services, but they are also entirely backed with comprehensive OINDP regulatory support specialists. Whether it’s a well-established regulatory approach or a leading-edge alternative pathway to achieve clinical study biowaivers, Nanopharm offers the expertise to seamlessly guide customers through the evolving regulatory landscape. As we focus only on OINDP development, our regulatory consultancy is also focused entirely on inhaled and nasal drug product regulations. Our goal is to accelerate and derisk your OINDP development project.

Nanopharm supports its intranasal and inhaled drug product development services with industry leading specialist OINDP regulatory consultancy. Let Nanopharm help guide you seamlessly through the complexities of OINDP filings from INDs to NDAs.

Our consultancy services include support for well-established bioequivalence pathways as well as new alternative non-clinical pathway options for a range of OINDP products.

Nanopharm’s development services bring with them the specialized regulatory knowledge and capabilities to help navigate customers through the complex and rigorous regulatory processes that advance intranasal or inhaled drug products. Whether it is supporting you through the well-established conventional regulatory pathways to file INDs, advance through clinical trials or filing an NDA, Nanopharm understands the regulatory requirements.  We’ve also participated in innovating alternative regulatory pathways that minimize your clinical study burden, using new technology and techniques that are supportable for streamlined regulatory submissions. We provide data and documentation in submission ready formats and our teams of respiratory experts help customers to avoid the pitfalls associated with complex OINDP filings. With unique in-vitro and in-silico technology and models, Nanopharm has worked closely with regulators to establish new non-clinical pathways to alternative bioequivalence that can reduce the timelines and costs of generic development programs.

The complexity of the drug delivery pathway for inhaled or intranasal drug delivery makes alternative bioequivalence more challenging than for simpler dosage forms such as oral solids or injectables. Nanopharm worked closely with major regulators as our experts developed its unique alternative pathway approach to non-clinical bioequivalence for OINDPs. Our SmartTrack™ platform provides an integrated in-vitro and in-silico based platform designed to deliver comparative bioequivalence for inhaled drug products, while avoiding the need for costly and time-consuming clinical studies. This innovation is fully supported with comprehensive regulatory support, provided by our experienced teams of OINDP specialists. Nanopharm helps customers to write and submit briefing documents to regulators from the earliest stages, and even attend meetings with the health authorities to ensure you have the experts on hand to ask and answer the right questions that derisk your regulatory journey. Whether it’s a well-established regulatory pathway to bioequivalence or an alternative non-clinical approach, Nanopharm has the regulatory support to advance inhaled and nasal drug product development programs to market.

Nanopharm OINDP Regulatory Support

Because Nanopharm is dedicated only to the development of intranasal and inhaled drug products, we offer highly specialized development services that you will not find elsewhere. Meeting the complex regulatory requirements that come with OINDPs, also requires specialists that understand the unique regulatory pathway these products require. Nanopharm is uniquely positioned as an expert in OINDP development and applies decades of regulatory experience to help streamline every development project with regulatory bodies.