OINDP cGMP Analytical Release & Stability Testing
Nanopharm offers the cGMP analytical testing services required for the release of clinical and/or commercial OINDPs. Our analytical method development scientists leverage their expertise in inhaled and orally inhaled drug delivery, combined with specialized laboratory equipment, to create dependable analytical testing methods. Whether it’s for OINDP release or stability programs, Nanopharm has the capabilities to efficiently develop, and validate cGMP analytical methods specifically for your nasal or inhaled drug product. Once your product is approved and marketed, our analytical laboratories can continue to provide timely cGMP product release and accelerated or long-term stability testing.
Nanopharm OINDP cGMP Analytical Release & Stability Testing
Nanopharm’s cGMP analytical laboratory services include specialized cGMP testing capabilities that deliver data and results suitable for regulatory submissions such as CMC sections, drug product characterizations (DPCs), and in-vitro bioequivalence (IVBE) studies. Nanopharm’s cGMP laboratories also support the timely testing and release of clinical batches so you can start your clinical studies on time and with confidence. Our in-house cGMP labs perform OINDP product testing for accelerated or long-term stability programs, confirming that your OINDP product formulations remain stable over time.
Nanopharm only develops and performs analytical testing for inhaled and intranasal drug products. Our dedicated scientists utilize an array of conventional and specialized analytical techniques in our cGMP qualified laboratory.
Our cGMP analytical laboratory offers in house stability storage for a range of ICH conditions. With accelerated or long-term stability program services, Nanopharm provides the stability testing needed to support the specialized needs of today’s OINDPs.
cGMP Release Testing for OINDPs
With a full array of conventional analytical equipment, complimented with extensive specialized aerosol and spray testing capabilities, Nanopharm can provide efficient release testing services for all OINDPs. Nanopharm’s in-house cGMP analytical testing services include specialized analysis such as emitted droplet and particle size distribution, aerodynamic particle size distribution, spray pattern, plume geometry, delivered dose uniformity/output rate, single actuation content, and dissolution tests. We also offer unique nasal and inhaled drug testing techniques not found elsewhere to fully characterize OINDPs for today’s regulatory requirements. All these analytical release testing capabilities are focused exclusively on providing high-quality cGMP testing services suitable for inclusion in CMC, DPC, and IVBE studies or as part of regulatory submissions. We provide analytical documentation in filing ready formats, including electronic common technical document (eCTD) formats, with timely and trusted results customers can rely on. These same cGMP analytical testing services are offered to support the efficient release of clinical trial materials (CTMs), so your clinical batches can get into the clinic on time. Whether it’s a fully commercialized product or a new clinical batch, Nanopharm’s analytical services provide complete cGMP release testing for a wide range of inhaled and intranasal drug products.
cGMP Analytical Stability Testing
Nanopharm extends its analytical services to stability testing. From new early phase clinical materials to commercialized inhaled or nasal drug products, our cGMP stability testing services cover a range of ICH storage conditions. We regularly perform cGMP analytical testing for everything from accelerated to long-term stability programs and provide reliable and efficient testing results suitable for all stages of a product’s shelf life. Our stability chambers are qualified, monitored and meet cGMP requirements with testing performed by analysts that only perform testing on orally inhaled or nasal drug products. Keep your cGMP stability program on track with Nanopharm’s stability testing capabilities.
Nanopharm cGMP Analytical Release and Stability Testing Solutions
Nanopharm’s specialized cGMP OINDP analytical testing services provide the data and documentation needed to support a range of regulatory requirements, all to current quality standards. Our fully qualified cGMP analytical laboratories and experienced analysts perform testing exclusively on inhaled and nasal drug products. That makes them uniquely qualified to conduct cGMP release and stability testing requirements for OINDPs.
