Research and Development Support
Testing support for product research and development.
Impact Analytical provides analytical testing to support drug product and medical device research and development. Impact’s scientists have a combined 300+ years of experience in analytical chemistry. We have experience developing material specific assays and methods for use in research support that can subsequently be utilized for final product testing. Our dedicated R&D support teams partner directly with the client to provide chemical and material testing support that ensures timeline integrity. This approach allows the client to access our experience and regulatory knowledge directly, saving time and budget.
Impact Analytical provides focused support for API development, assay and impurities methods development, container closure material selection, stability, drug or material compatibility, extractables, accelerated stability, and medical device material selection. This support can be leveraged from development through preclinical, phases I and II, and final product manufacture.
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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. We assist our clients with pharmaceutical development; method development, validation, stability, formulation, batch release and extractables/leachables.
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.
Look to a partner who can quickly get you over the hurdles and safely to market in today’s global pharmaceutical industry.
Pharmaceutical Related Services and Techniques