Make A Major Impact.
Accurate testing results with the rapid turnaround you expect. Impact Analytical provides testing support for pharmaceutical companies during preclinical, phase I, II and III of the drug development process for both small and large molecule APIs and drug products.
Analytical testing during drug development is required and governed by the FDA. Although the FDA does not specify details of how the tests should be conducted, they do specify how they must be documented and the depth of testing that’s required. We are well versed in the FDA and regulatory guidelines to ensure your testing complies with your specific requirements. As a pharmaceutical manufacturer, it’s important for you to partner with a lab that has a quality system in place and can perform testing per cGMP, following 21 CFR guidelines spelled out by the FDA. To learn more about our rigorous quality system please visit Impact Analytical Quality System.
Pharmaceutical Testing Services
Below is a list of pharmaceutical testing services we routinely perform for the industry. Our pharmaceutical testing lab provides services for both small/large API's and drug products.
- Molecular Characterization
- Method Development and Validation
- Stability Testing
- Batch Release Testing
- Raw Material Characterization
- Extractable/Leachable Analysis
- Pharmaceutical Dissolution Testing
- Impurity Identification
- USP <661> - Characterization of Packaging Systems
Your medicine can make a major impact. Look to a partner who can quickly get you over the hurdles and safely to market in today’s global pharmaceutical industry.
Complete list of services: