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R&D and Validation Activities

R&D and Validation Activities

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)
  • 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

Development & Validation of Methods

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Forced Degradation Studies

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Identification of Foreign Particles

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Identification of Unknown Impurities

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