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).

As part of the validation process, our experts check the following:

  • Specificity (including stability-indicating verification)
  • Accuracy
  • Precision (repeatability, intermediate precision, reproducibility)
  • Limit of detection
  • Limit of quantification
  • Linearity
  • Range
  • Robustness
  • 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.

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Contamination of pharmaceutical products by microorganisms is a major risk within the pharmaceutical industry, with a potential impact on product integrity and patient safety.

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A medical device, or a material used in a medical device, that comes into direct contact with patients must be able to perform its intended function without inducing significant rejection.

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Mérieux NutriSciences provides a comprehensive range of microbiological services relating to medical devices, to support facility and product monitoring, as well as product development and registration.

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In relation to pharmaceutical products and medical devices derived from raw materials of animal origin, for which the raw material may contain viruses that are dangerous to human health...

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Mérieux NutriSciences performs a wide range of toxicology studies designed to assess the safety of chemicals, pharmaceutical products and excipients.

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The products offered by the medical device sector are subject to various biocompatibility regulations, depending on the intended application and complexity of the device.

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Mérieux NutriSciences has a proven track record in carrying out studies of extractables and leachables in order to detect very low levels of contaminants from materials in contact with medicinal products and medical devices.

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Mérieux NutriSciences offers method development and validation solutions for every analytical challenge, through the availability of several qualified analytical techniques in specialized GMP labs.

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Forced degradation is synonymous with stress testing and plays a key role in the development of stability-indicating and analytical methods, establishing operative conditions and the design of formulations.

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The identification of pharmaceutical impurities is a critical analytical activity in the drug development process. 

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Foreign particles can be a problem in many industries, including the pharmaceutical sector. 

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