Service Category

(Bio) Pharmaceuticals

In the field of life sciences, pharmaceuticals are complex and implications to human health and the environment can vary across a drug's life cycle. Gradient scientists bring expertise applicable to a wide range of issues, offering comprehensive support throughout the drug development process. At the target identification stage, Gradient scientists provide technical and strategic solutions for preclinical toxicological safety assessments, facilitating screenings of various pharmaceutical entities, including new pharmaceutical targets, active pharmaceutical ingredients (APIs), excipients, impurities, extractables, leachables, and other pharmaceutical entities for potential health hazards and risks. In-house expertise in alternative testing strategies facilitates comparative toxicity screens for hazard and risk assessment of unusual and proprietary chemicals. Our epidemiologists regularly provide critical reviews of clinical trials and observational studies to evaluate the efficacy and safety of specific pharmaceuticals. Our services apply to the release of chemicals into the environment related to manufacturing, consumer use, and disposal, as well as the potential impacts to wildlife from antibiotic resistance or endocrine disruption. Gradient scientists also contribute their toxicology expertise to regulatory and marketing submissions and can assist with interactions with regulatory bodies, including the US Food and Drug Administration (US FDA) and European Medicines Agency (EMA).