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 evolving regulatory processes and providing them with filing-ready data and documentation.
As specialists in inhaled and nasal drug product development, we understand the intricacies of regulatory requirements in this niche field. With over two decades of experience, Nanopharm has cultivated deep expertise in both conventional and alternative regulatory pathways. We share this knowledge through tailored consultancy services that help clients meet regulatory standards with confidence.
The regulatory framework for nasal spray and inhaled drug products is well-established, incorporating analytical tests, measurements, and human clinical studies to demonstrate bioequivalence. However, newer alternative pathways—designed to reduce or eliminate clinical studies—can be less clearly defined. Nanopharm is at the forefront of developing and applying innovative in-vitro and in-silico bioequivalence approaches to support these emerging routes.
Expanded CMC Consulting Capabilities
Through Aptar Pharma’s acquisition of clinical trial manufacturing capabilities, Nanopharm now benefits from the added expertise of Aptar Boonton, further strengthening our regulatory and development services.
Aptar Boonton provides expert CMC (Chemistry, Manufacturing, and Controls) consulting to ensure seamless drug development from concept into the clinic, with services aligned to the latest regulatory requirements for quality and consistency.
For a drug product to meet the rigorous standards required by healthcare regulators, it is essential not just to document programs and processes, but to document them in the right way. Aptar Boonton provides expert regulatory writing services for Module 3 submissions, ensuring compliance with global healthcare authorities like the FDA, EMA, and ICH. Their extensive experience in clinical development and cGMP manufacturing ensures the accurate documentation needed for successful drug product approvals, bridging the product development work performed by Nanopharm into a robust regulatory submission to get you safely into the clinic.
This integration enhances our ability to support clients from early development through regulatory submission and clinical supply, ensuring that every stage of the product lifecycle is aligned with global regulatory expectations.
End-to-End Regulatory Support
Nanopharm offers comprehensive support across the regulatory journey, including:
- Preparation of filing-ready data packages
- CMC content for regulatory submissions (e.g. Module 3 of IND)
- In-vitro and in-silico bioequivalence strategies
- Guidance through regulatory reviews and agency interactions
- Representation at pre-ANDA or pre-IND meetings
As innovators in non-clinical bioequivalence for nasal sprays, pMDIs and DPIs, we help clients advance their products toward clinical trials or market authorization with greater speed and confidence.
Whether you’re pursuing a conventional regulatory pathway or exploring alternative approaches, Nanopharm’s consultancy services—now enhanced by Aptar Boonton’s CMC expertise—are designed to de-risk your development and accelerate your path to approval.
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.
