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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Analytical testing in support of an ongoing legal case.
Litigation cases involving materials, chemicals, pharmaceuticals or unknowns can require third-party testing support. Impact Analytical has protocols in place to facilitate testing in support of legal cases requiring the utmost confidentiality, sample security, custom reporting needs and expert witness testimony (if needed). Our secure, locked sample receiving area ensures 24-hour control of samples at all times. We staff at least one Ph.D. level scientist in each of our laboratories who can serve as an expert witness if desired. Our scientists provide depositions that are devoid of opinion and backed by sound analytical technologies. Samples of cases handled in the past include: