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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Thorough Examination. Sound Conclusions.
With the combination of experienced analytical scientists and a rigorous quality program, Impact Analytical has become a major supplier of analytical services to the medical device industry. We are meticulous and detailed. We will find the cause of your material or device problem. Our scientists have expertise analyzing a wide range of sample types, including plastics, raw materials, chemicals, contaminants and gases. Impact Analytical’s quality program includes a full-time quality manager, a four-person audit team and an experienced quality assurance unit (QAU).
Impact Analytical is ISO 9001:2008 certified and GLP/cGmP- compliant.