OINDP cGMP Release & Stability Testing
Whether you are going into the clinic or releasing marketed products, OINDPs require specialized cGMP analytical testing to ensure they meet specifications for patient safety and drug efficacy. Nanopharm is dedicated to providing only OINDP analytical testing. That means you have access to highly specialized analytical testing services from Nanopharm’s qualified cGMP laboratory supporting the release and stability testing requirements of your OINDP clinical trial materials (CTMs). Once your product is approved and marketed, our cGMP laboratories can continue to provide timely release testing for even the most specialized test methods.
Nanopharm OINDP cGMP Release & Stability Testing
Nanopharm’s cGMP analytical laboratory services are designed to exclusively support orally inhaled and intranasal drug product testing requirements. We’ve built specialized cGMP testing capabilities that deliver data and results suitable for CMC, drug product characterization (DPC), and in-vitro bioequivalence (IVBE) studies for inclusion in regulatory submissions. 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 laboratories can perform OINDP product stability testing for accelerated or long-term stability programs, making sure your OINDP product formulations remain stable over time.
Nanopharm’s cGMP release testing is exclusively focused on inhaled and intranasal drug products utilizing an array of specialized and conventional analytical techniques in our cGMP qualified laboratory.
Our cGMP analytical laboratory offers in house stability storage in a range of ICH conditions. Nanopharm’s cGMP laboratory supports stability study requirements for short or long term, accelerated or in use studies, to help set the shelf life specifications and ensure your product remains stable.
cGMP Release Testing for OINDPs
Nanopharm’s analytical services provide complete cGMP release testing for a wide range of inhaled and intranasal drug products. 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. Our cGMP in-house analytical testing options include 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 to name a few. We also offer proprietary and unique nasal and inhaled drug testing techniques to fully characterize OINDPs for today’s regulatory requirements.
All of these capabilities are focused exclusively on providing industry leading cGMP analytical release testing services that are suitable for inclusion in CMC, DPC, and IVBE studies for regulatory submissions. We provide documentation in filing ready formats, including electronic common document (eCTD) formats. Nanopharm makes it easier for our customers, with timely and trusted results they 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 with their safety assured.
cGMP Analytical Stability Testing
Nanopharm’s cGMP analytical testing services are also designed to support your ICH stability testing needs. The same comprehensive cGMP analytical testing services are available to perform product stability testing for in-use, accelerated or long-term stability programs. This ensures that customer intranasal and inhaled drug products, whether they are clinical or marketed products, can receive the same reliable and efficient analytical testing services at all stages of their shelf life. Our on-site storage chambers cover a range of ICH conditions and are fully qualified. They meet cGMP standards and all samples are tested to the highest quality standards by analysts that specialize in testing orally inhaled and nasal drug product testing only. Keep your cGMP stability program on track with Nanopharm’s cGMP stability testing capabilities.
Nanopharm cGMP Analytical Release and Stability Testing Solutions
Nanopharm’s specialized cGMP OINDP analytical testing services can provide the data and documentation needed to support a range of filing types to current quality standards. Our fully qualified cGMP analytical laboratories and analysts exclusively test inhaled and nasal drug products. That makes them uniquely qualified to bring their decades of focused experience to cGMP release and stability testing requirements of OINDPs.
