Mérieux NutriSciences - Medical Device services

Our services include: • Quality controls • Investigation studies • Absorption studies • R&D and validation activities • Stability & storage • Cleaning and disinfectants validation Download our brochure: https://bit.ly/48HKnVs

Mérieux NutriSciences has developed various strategies and complementary approaches for the identification of foreign visible and subvisible particles, thanks to sophisticated instrumentation combined with a pool of experts in different fields.Download our brochure: https://bit.ly/48HKnVs

Thanks to specialized laboratories, a GMP pharmaceutical division and a global network of experts at Merieux NutriSciences, we have expanded our expertise in the dietary supplements and food supplements sector. We are able to offer a complete service to support companies in ensuring dietary supplements qua...

In vitro models mimicking different biological barriers can be adopted to perform absorption studies and evaluate efficacy of products, ingredients or new formulations before to proceed with the next step evaluation (e.g. clinical trial). In vitro methods are less expensive, faster, and offer better contro...

Pharmaceutical Laboratory Services - One-stop shop pharma facility.
Mérieux NutriSciences is a valued partner to the global healthcare industry, offering research, development and quality control testing of pharmaceutical products.
From active ingredients to finished products, we offer a complete range of analytical and research services for API and pharmaceutical products.Our services include safety and quality control, development and validation of analytical methods. Our fully equipped, state-of-the-art laboratories offer comprehensive testing services according to the current pharmacopoeia. We also provide tailored solutions according to customer specifications.

The first alert from regulatory authorities was in mid-2018 when nitrosamine impurities - including N-nitrosodimethylamine (NDMA) - were detected in sartans-based pharmaceutical products. This triggered a series of global-scale investigations that led to the revelation of the presence of other low molecular weight N-nitrosamines in many APIs and finished products, sometimes forcing companies to recall products. Successively, a new risk was highlighted related to the formation of NDSRIs from APIs (or their related impurities) containing vulnerable amine groups during finished product formulation/storage due to the reaction with residual nitrite present in some raw materials. This new emerging issue affected several drug products on the market, stimulating the Competent Authorities to push for a review of the original risk assessment in light of this new information performing step 2 confirmatory testing as appropriate.
Our scientific expert will talk about: NDSRIs emerging issues Analytical challenges during method development and QC tests on NDSRIs Case studies from Mérieux NutriSciences Pharma Nitrosamines Labs