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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Impact Analytical has a full breadth of testing services to meet all your testing needs. We offer both routine and problem solving services. A full report outlining the project objectives, procedures/methods employed, data and results is delivered with each project. Customized reporting is available as well. Testing can be performed utilizing standardized methods (ASTM, USP, ISO, etc.), Impact Analytical in-house methods, customer supplied methods, or under newly developed methods. All testing results get a full QC review, either under our ISO 9001:2008 quality system, under GLP (FDA or EPA), or under cGMP (FDA) as needed. The full list of our services is in the scrollable list at right, and quick links to some of our common services are below.