Our Services

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.  

Data Elements: OurServices.aspx

Services Method Development & Validation

Development and/or validation of analytical methods specific to your sample matrix, active ingredient and desired instrumentation.

Impact Analytical provides method development for a full range of capabilities and customizes methods for your analyses of interest (API, intermediate, formulation or finished product) and sample matrix. All methods are developed with your end goal in mind – whether it’s validation, transfer, QC usage, cGMP release testing or others.

Impact Analytical also offers method validation services for methods developed at Impact Analytical or elsewhere. Our compliance with both GLP and cGMP ensures all validation needs can be met throughout the drug development lifecycle. Validation can be performed in accordance with the client’s SOP or protocol and is done to FDA and/or ICH guidelines. Typical validation elements include:

  • Accuracy

  • Analyst precision

  • Intermediate precision

  • Limit of detection

  • Limit of quantitation

  • Linearity

  • Range

  • Robustness

  • Ruggedness

  • Specificity

  • System suitability