Our experts regularly work with clients to develop and validate bespoke tests, which are subsequently used to provide evidence of product conformity for regulatory submissions.

For each test method a study protocol is prepared by one of our test experts to clearly define the procedures we will employ.

Validation testing to determine:

  • Repeatability
  • Reproducibility
  • Robustness
  • Accuracy

Documentation:

  • Test protocols and reports
  • Validation protocols and reports
  • Supporting documentation such as calibration records
Testing is performed in accordance with the protocol created in the method development phase and the results are then assessed.

We work with clients to prepare approved documents to provide evidence of conformity for FDA and EU regulatory submissions.