Gradient scientists bring expertise to a wide range of issues, from offering comprehensive support throughout the new drug development process to assessing effects on humans and the environment of pharmaceuticals already in use. We also contribute to the toxicology- and ecological effects-related sections of regulatory submissions.
What We Do
We advise companies regarding the safety of new drugs, prepare assessments to support regulatory filings, and frequently interact with regulators, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Provide technical and strategic solutions for preclinical toxicological safety assessments
Perform epidemiological review of clinical trial and observational study data to evaluate efficacy and safety
Evaluate the potential role of exogenous compounds that may alter behavior, produce tissue damage, or result in other undesired effects
Analyze the effects of drugs on behavior and health outcomes
Support development of gene and cell-based therapies through research and development (R&D), manufacturing, preclinical, and clinical stages
Use forensic toxicology to determine if links exist between chemicals detected in biological media and observed health outcomes
Assess the impact of pharmaceuticals in the environment (PIE) on ecological receptors, including the potential for endocrine disruption
Develop environmental fate and effects data and decision frameworks to assess potential environmental risks of existing and new active pharmaceutical ingredients (APIs)