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Regulatory Consultancy

Nanopharm is pioneering new, alternative non-clinical pathways to bioequivalence for Orally Inhaled and Nasal Drug Products (OINDPs). Our expertise enables us to offer comprehensive regulatory support, assisting clients in navigating the complexities of new regulatory processes and providing them with filing-ready data and documentation. Our role extends to guiding clients through regulatory reviews, leveraging our innovative in-vitro and in-silico bioequivalence approaches.

The intricacies of regulatory requirements for OINDPs demand dedication and focus. Specializing in the development of inhaled and nasal drug products, Nanopharm has cultivated an in depth expertise in this niche field. Over two decades of experience has equipped us with a deep understanding of the regulatory landscape for nasal and inhaled drug products. We share this wealth of knowledge through our consultancy services, helping clients meet regulatory standards with confidence.

Nanopharm OINDP Regulatory Consultancy Services

The regulatory framework for nasal spray and inhaled drug products is well-established in existing regulations and guidelines that incorporate analytical tests, measurements, and human clinical studies to establish generic bioequivalence. The same clarity is not always apparent with newer alternative regulatory pathways that eliminate or reduce the number of clinical studies required. Nanopharm are experts in conducting development programs for Orally Inhaled and Nasal Drug Products (OINDPs) that adhere to conventional regulatory requirements, while also offering an innovative, proprietary non-clinical pathway for inhaled drug products.

As innovators in creating alternative non-clinical pathways for the bioequivalence of generic metered-dose inhalers (MDIs) and dry powder inhalers (DPIs), Nanopharm is equipped to navigate the intricate regulatory landscape for these products. Our expertise enables us to assist clients in advancing their products towards clinical trials or market authorization effectively. We offer comprehensive support ranging from the preparation of filing-ready data packages and Chemistry, Manufacturing, and Controls (CMC) submission content to guiding clients through regulatory reviews with our in-vitro and in-silico methodologies. Clients can depend on Nanopharm for specialized consultancy support tailored to the unique challenges of bringing inhaled drug products to market and we can even accompany you to pre-ANDA or pre-IND meetings to provide our expertise directly to the regulators on your behalf.

Nanopharm has applied its decades of industry leading experience in developing advanced nasal and inhaled drug products to be able to provide specialized regulatory support that brings OINDPs to the clinic.

Nanopharm offers development services along with regulatory consulting support to establish bioequivalence through both traditional and innovative non-clinical alternative pathways, that can meet regulatory standards.

Nanopharm has developed a non-clinical in-vitro in-silico platform called SmartTrack™, that can demonstrate bioequivalence via an accelerated alternative pathway with exclusive regulatory consulting support included. We can prepare pre-submission documents to help you get clarity from regulators on what they expect from you and join you in critical meetings with regulators.

OINDP Regulatory Experience and Consulting Services

Because Nanopharm has been entirely dedicated to advancing the development of inhaled and nasal products for more than two decades, we are established experts in the field. Nanopharm’s experience and specialized scientific capabilities have been applied to several of the world’s leading nasal and inhaled drug products. Our comprehensive drug product development programs have always included supporting customers with the knowledge and deliverables that always meet evolving OINDP regulatory requirements. We design development programs to meet the requirements of current regulatory filing needs. Nanopharm provides data and documentation in filing ready formats to make it simple for customers to complete their regulatory submissions.  We provide guidance and support every step of the way to make sure our customers avoid regulatory shortfalls. It takes a specialized CRO like Nanopharm to provide the integrated regulatory support needed to advance OINDPs.

Established Test and Metrics for Conventional Regulatory Pathway

The U.S. FDA has defined the requirements for establishing bioequivalence for generic nasal aerosols and local acting nasal sprays. This includes specialized testing particular to nasal drug products. Nanopharm has all the required capabilities to meet these clearly defined requirements including Single Actuation Content (SAC), droplet size distribution by laser diffraction, drug in small particles/droplets, particle droplet size distribution, drug particle size distribution by microscopy, spray pattern, and plume geometries. Nanopharm is fully equipped to perform all of this analysis along with the regulatory support needed. As specialists in OINDP product development, Nanopharm has the scientific experience and laboratory capabilities needed to efficiently generate required data in filing ready formats for customer products. Conventional U.S. FDA guidance also requires the customer perform human clinical studies to complete the bioequivalence requirements needed for approval.

Regulatory Support & Innovating an Alternative Pathway

Nanopharm has been charting new alternative pathways to bioequivalence waivers for inhaled drug products through its proprietary SmartTrack™ Platform. Our scientists have created a multidimensional approach that includes innovative in-vitro and in-silico modeling that can replace costly and time consuming Comparative Clinical Endpoint (CCEP) studies which are normally required to demonstrate the bioequivalence of new generic inhaled drug products. This proprietary SmartTrack™ platform can save millions of dollars and years in clinical trials with a more robust and representative alternative pathway. SmartTrack™ was only made possible because of Nanopharm’s commitment to the innovation of OINDP development services. As regulations are a critical part of a new alternative pathway, Nanopharm has been collaborating on this new approach with regulatory bodies such as the U.S. FDA, ensuring that it complies with their expectations.  We support our customers with regulatory support, step by step through the alternative pathway process, including preparing pre-submission documents and accompanying you into meetings with regulators to help ensure you get the answers you need to progress to the market. Click here for more information on our alternative bioequivalence regulatory support services.

Nanopharm Complete Regulatory Support

As a specialist in the development of OINDPs, Nanopharm offers extensive experience in advancing customer OINDPs by both conventional and alternative non-clinical pathways to bioequivalence. Nanopharm’s scientists are experts in both approaches for OINDPs and apply their specialized expertise to every customer project, building in our regulatory consulting support every step of the way.