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Analytical Methods
Do you have a company policy concerning the methods to be used in your projects?
Have you from the start decided if a method should end up in a specification or a pharmaceutical development report or even as early proof of concept for “internal use” and eventually Due Diligence?
Qsol can offer expertise in all phases of the life cycle of a method:
- What to test in different phases of a project
- The validation steps from early verification to full GMP validation
- Development reports
- Writing the method
- Validation protocol
- Validation of methods in your own lab using relevant equipment, personnel etc.
- Validation reports
All in compliance with both EU and FDA regulations.
At Qsol we have a long experience in the world of dissolution and we can offer to help developing methods fit for purpose.
Contact: tel@qsol.dk |
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