In House Method Development
Building on a long-standing history of expertise in the development and validation of analytical methods, NUVISAN has internal capabilities to conduct method development and optimization for your in-house methods and products.
Non Clinical Release
Based on your drug product specification, our GMP Teams will perform the testing and release of your non-clinical supplies with certificates of analysis.
Pre/Post Study Testing
NUVISAN supports drug analytical testing for toxicological studies with an adaptive approach that is in line with regulatory requirements at this early stage. Testing done pre- and post-study will ensure that the quality of your drug remains unchanged while avoiding multiple assays.
Non Clinical Analytical Package
NUVISAN supports non-clinical studies with dedicated teams of experts in Pharmaceutical Analytics. We will implement and develop the appropriate set of analytical methods specifically adapted to the development stage of your product.
Clinical Phase I
Clinical Release Testing
Once the drug product specification is defined, our GMP certified laboratories will ensure timely release of your clinical trial supplies in compliance with GMP practices and in accordance with ICH/VICH guidelines. Our three GMP facilities have established analytical platforms that enable NUVISAN to scale the analytical work according to your requirements within short lead times. In addition, our centers of excellence can propose specific analytical techniques customized to your needs – all under one roof.
NUVISAN’s integrated approach allows quick transition between the clinical stages.
NUVISAN also supports in-house microbiology testing with Preservative Efficacy and Microbial Limit Tests (USP & Eur Ph) within our dedicated laboratories.
Early Clinical Analytical Package
While preparing for the first clinical study, working along the analytical continuum will ensure the best approach to support Phase 1 requirements.
Our analytical experts will develop the required stability indicating methods including fit-for-intended-use validation in order to reliably characterize your clinical supplies.
Package : Stability Chambers Capabilities
Among our 3000 m² GMP laboratories, we can provide superb support thanks to stability chambers with more than 320 m² of storage, and with a wide range of temperatures from -70°C to +60°C (zone I to zone IV). We also offer Cycling studies, Compatibility studies, as well as Photostability and Transportation Studies, in addition to sample storage.
Thanks to large capabilities in terms of stability chambers, NUVISAN can support you with designs of ICH stability studies required for your regulatory submission.
Clinical Phase II
Full Clinical Analytical Package
NUVISAN offers analytical characterization in order to support the drug development for products entering into Phase 2 stage.
Our experts have the expertise and experience to accompany your projects through this crucial stage of drug development.
Among our 3000 m² GMP facilities, NUVISAN is equipped with stability chambers, climate cabinets and standalone stability storage equipment to provide the best solution for stability studies during all Phases of drug development.
We offer a large variety of parameters (e.g. temperature, humidity, light) to meet all regulatory (ICH) and product specific storage requirements, with a range of temperature from -70°C to +60°C, also covering ICH zones I to IV.
Clinical Release Testing
Taking the benefit of the data generated during early stages, we will complement the analytical method portfolio to be fit for testing under GMP regulations, including forced degradations and robustness studies.
With our integrated approach, NUVISAN supports your project during definition of the best drug product specification for IMPD and IND filings. Once the product is available, we will perform quality control and can adapt to any local requirements to make sure the quality will target all regulatory expectations for world-wide clinical trials.
NUVISAN also supports in-house microbiology testing with Preservative Efficacy and Microbial Limit Tests (USP & Eur Ph) in our dedicated biosafety laboratories.