Technology transfer

Analytical method and validation advice

Our support with analytical methods will enable you:

-To set up and validate methods quicker
-To ensure that methods are compliant with regulatory requirements.

Essential steps in method development

The development includes methodologies on how to separate, identify and quantify the chemical and biological components of a pharmaceutical product.

An analytical method shall characterize and control starting materials, intermediates, excipients, drug substances, and drug products.

This is how purity, potency and limits for impurities are established.

In the end, this practice is critical to ensuring and demonstrating the quality of your drug product.

Then, there is also method validation, which shows that the analytical method is suitable for its purpose. Validation is largely regulated by harmonised regulatory guidelines accepted worldwide.

Why use our support with analytical methods and validation?

Within Arex Advisor we have experts with academic backgrounds in analytical chemistry as well as industry experience in developing and setting up appropriate methods.

Analytical Methods Advice:

  • Method development and optimisation
  • Method validation and verification
  • Stability testing and characterisation
  • Regulatory submission support

We can guide you through the validation process as well as selecting appropriate limits in your specifications.

More technology transfer services

Technology transfer support

Staffan Thunell

Founding partner

BSc Economics and BA

Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from posit­ions as Founder, Chair­man, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.