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
Impact Analytical provides support for packaging services for Household, Pharmaceutical, Health & Beauty and associated industries.
Quality control in the packaging industry is of foremost importance, as contact with the finished product can lead to cross contamination. Weight, design, and material selection are controlled to ensure a cost competitive option is achieved without compromising the integrity of the finished product. Poor material selection can lead to changes in a product’s integrity (taste, odor), safety, or present a risk to either the consumer (degradation) or environment, affecting brand name and consumer confidence.
For packaging identification, we use advanced analytical techniques such as microscopy and fourier transform infrared spectrometry (FT-IR). These instruments can be teamed to characterize multi-layer packaging materials for layer thickness, morphology, and ID. However, the best equipment in the world is useless without an expert team of technicians or analysts who know how to operate it. Our highly-trained staff is ready to provide dependable packaging solutions. Our scientists have many years’ experience in polymer characterization, chemical testing for coatings, additives, ink, adhesives and multi-layered materials, physical testing, and quality testing to comply with vendor standards. Testing expertise also includes investigative problem solving to support product development, failure, or compliance requirements for a range of packaging materials such as plastics, glass, metals, paper, paperboard, and textiles.
Issues related to banned substances such as Bisphenol A and phthalates are routine for the scientists of Impact Analytical; let us resolve your packaging concerns.
Packaging Related Services and Techniques