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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Material and product testing under FDA or EPA guidelines.
Analytical support of the development and manufacturing of FDA and EPA regulated products is vital. This support must be performed with strict adherence to the appropriate FDA or EPA guidelines for the product in question. Impact Analytical has a robust quality system allowing us to perform analysis across all our laboratories for both FDA and EPA regulated studies.
Examples of FDA and EPA regulated studies we’ve performed in the past include:
We are ISO 9001:2008-certified, GLP-compliant, cGMP-registered and DEA-licensed. Our two FDA and one EPA facility audits, to date, have resulted in no major or minor findings. For more information, visit our quality section.