At ALS we have a proven track record of delivering method development and validation projects across a range of analytical methodologies.
Test Method Development and Validation
We are highly experienced in test method development and validation across various analytical techniques and product types in compliance with regulatory requirements.We can assist throughout the entire process including project planning, protocol preparation, and analytical testing to final project report.
Key test method areas in which we have expertise include:-
- Dissolution profile studies
- Compendial methodologies bespoke to your product formulation
- Stability indicating test methods to comply with ICH
Analytical Method Transfer (AMT)
Analytical Method Transfer (AMT) is performed as standard prior to conducting routine release testing in accordance with regulatory requirements.
Analytical method transfer is critical to ensure continuity of data and with our experience in performing this comparative testing we can assist you throughout the entire process; from protocol preparation including guidance on testing requirements and acceptance criteria, analytical testing to final transfer report.