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.
Our support with analytical methods will enable you:
-To set up and validate methods quicker
-To ensure that methods are compliant with regulatory requirements.
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.
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:
We can guide you through the validation process as well as selecting appropriate limits in your specifications.
Erik Hedner
Arex Advisor AB
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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.