Analytical method 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. We can guide you through the validation process as well as selecting appropriate limits in your specifications.
What is the result for you and your project?
Our support with analytical methods will enable you:
- to set up and validate them quicker
- to ensure that they are compliant with regulatory requirements.