Developing and Validating Pharmaceutical Methods

Entwicklung und Validierung von Analysenmethoden Pharma

Detecting active ingredient content or testing purity and stability - we have developed a range of methods for various tasks in the pharmaceutical industry to ensure reliable results.

Developing analytical methods

When developing new analytical methods, our experienced analysts are able to grasp the intricacies of your problem thanks to their expertise and product knowledge. They work with you to develop methods for topics such as

  • Identity
  • Quantifying primary components and active ingredients
  • Quantifying secondary components, e.g. degradation products
  • Limit testing

Analytical methods according to international pharmaceutical standards

Analytical methods are validated and documented in accordance with international standards (GMP, ICH, VICH). As pharmaceutical regulations change and become stricter, this poses a challenge for the industry. You need to have complete confidence that finished medicinal products, raw materials and active ingredients are tested in accordance with current guidelines.

We are also happy to advise you on the scope of the validation and which service components are relevant for your specific task.

Verifying pharmacopoeia tests

On request, we are pleased to carry out method verifications of pharmacopoeia tests, also according to USP <1226>. Traditional method validation is used to demonstrate that a particular method is suitable for the intended application. Method verification tests the suitability of a pharmacopoeia method in a particular laboratory and for a manufacturer’s specific product (pure substance or finished medicinal product).

From contract laboratory to know-how transfer

Make the most of our expertise, methods and techniques, taking advantage of as much flexibility and efficiency as your tasks require. For example, you can hire us as an outsourced contract laboratory, carry out comparisons on the basis of our results, or put the application to use in your own laboratory.

GMP compliance

Our GMP compliance is regularly confirmed during inspections by national and international authorities. More than anything else, auditors recognize just how highly qualified our staff is in supplier audits of pharmaceutical companies.

Current GMP certicicate

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