Additional Description:
Wilmington PharmaTech offers a full suite of analytical testing supporting in-process, release, and stability testing: analytical method development and validation; full GMP release testing for clinical and commercial API; non-GXP and GLP testing; reference standards and impurity work (reference standard prep, impurity identification and characterization, impurity standard preparation and qualification); stability and regulatory support (ICH stability studies including trace impurity analysis); and genotoxic impurity services (risk assessment reports, reference compound support, control strategy development, method development/qualification/validation, and sub-ppm trace impurity analysis for RSMs, APIs, and intermediates).
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