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
Our most common tests and services
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.
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.
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).
We can support your new compound or innovative food product by generating scientific evidence through randomized clinical trials.
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.