Mérieux NutriSciences is a valued partner to the global healthcare industry, offering research, development and quality control testing of pharmaceutical products and medical devices.
From active ingredients to finished products, we offer a complete spectrum of analytical and research services for medicinal products and medical devices. Our services include safety and quality control, development and validation of analytical methods, and bioanalytical testing.
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.
Our services include:
- Quality control (link)
- Safety (link)
- R&D and validation activities (link)
- Clinical research (link)
- Stability & storage (link)
Pharma and Medical Devices services are not offered on site in our South African laboratories, however, our international network supports us to meet your requirements. For further information, please contact our Customer Care team.
All our Tests and Services
Mérieux NutriSciences offers a complete portfolio of GxP-compliant studies and laboratory analyses useful for the release of raw materials and finished pharmaceutical products, as required as part of the drug manufacturing, development and commercialization process.
We also offer a set of tests to be carried out on medical devices.
Mérieux NutriSciences performs:
- Physicochemical tests
- Physicochemical tests on pharmaceutical products
- Physicochemical tests on medical devices
- Microbiological and biological tests
- Microbiological and biological tests on pharmaceutical products
- Microbiological and biological tests on medical devices
In order to distribute a new pharmaceutical product or medical device on the market, all applicable regulatory standards for safety and quality must be met.
Mérieux NutriSciences offers a complete portfolio of GxP-compliant studies and laboratory analyses to ensure the safety of active pharmaceutical ingredients (APIs), excipients, finished products and medical devices.
To verify the safety and quality of your products or medical devices, our laboratories provide the following:
- Viral clearance
- Toxicological studies
- Ecotoxicological studies on APIs, pharmaceutical products and excipients
- Leachables and extractables
Quality is always an essential factor in relation to any product, and it takes on even greater importance in the case of life-saving products such as pharmaceuticals.
Validation consists of obtaining overall approval for a sequence of activities in order to demonstrate and provide documentary evidence that a specific product can be reliably manufactured via the processes in question (thus, it is closely related to substance quality).
Thanks to our highly qualified experts and state of the art instruments, Mérieux NutriSciences is able to offer services such as:
- Method development and validation for pharmaceutical products and medical devices
- Forced degradation studies
- Identification of unknown impurities
- Identification of foreign particles
As part of the validation process, our experts check the following:
- Specificity (including stability-indicating verification)
- Precision (repeatability, intermediate precision, reproducibility)
- Limit of detection
- Limit of quantification
- Stability of the solution
Stability testing provides evidence of how the quality of an active pharmaceutical ingredient (API), medicinal product or medical device varies over time. This approach also takes into account the influence of a variety of environmental factors, such as temperature, humidity and light.
Stability testing also evaluates the potential interaction of a medicinal substance with other active ingredients or excipients, as well as contact with the container closure system and packaging materials.
Mérieux NutriSciences performs accelerated, intermediate and long-term stability studies and photostability studies to ensure the regulatory compliance of active ingredients, medicinal products and medical devices.
We offer the following stability conditions for pharmaceutical stability storage:
- 25°C ± 2°C / 60% RH ± 5% RH
- 30°C ± 2°C / 65% RH ± 5% RH
- 30°C ± 2°C / 75% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH
All climatic conditions are continuously monitored using BMX eviSENSE LabguardTMsoftware, ensuring a totally secure and controlled environment.