Associate Industry Health & Safety ConsultingCambridge, MA
Since 1985, Gradient has employed sound science to assist national and global clients with resolving their complex environmental and human health challenges. Renowned for our specialties in Toxicology, Epidemiology, Chemistry, Biology, Ecology, Industrial Hygiene, and Public Health, our scientists are nationally recognized experts and active contributors to the advancement of knowledge for science solutions.
For biopharmaceutical and medical device companies, Gradient scientists provide expertise throughout the development process, from preclinical safety assessments to regulatory submission. At the target identification stage, our toxicology team offers technical and strategic solutions for pre-clinical toxicological safety assessment. We have specialized expertise in alternative testing strategies, including read-across and various in silico tools (Derek NexusTM, Leadscope, OECD QSAR Toolbox, Toxtree). We also facilitate comparative toxicity screens for hazard and risk assessment of unusual and proprietary chemicals. Our epidemiologists and statisticians critically review clinical trials and observational studies to evaluate the efficacy and safety of specific pharmaceuticals. Our environmental team assists clients with assessing and communicating risks associated with pharmaceuticals in the environment (PIE). To our clients, we provide independent unbiased assessment of complex scientific matters.
Gradient's main offices are in Cambridge, Massachusetts, and Seattle, Washington. Over 50% of our staff hold Ph.D.’s.
Some of our biopharmaceutical and medical device services include:
- Laboratory selection and oversight
- Nonclinical and environmental toxicology program development and oversight (including inhalation, dermal, oral, and intravenous exposure routes and implants)
- Alternative testing strategies (read-across, in silico tools, QSAR)
- Hazard and risk assessment of pharmaceuticals, biopharmaceuticals, and other advanced materials (e.g. nanomedicine, nano-enabled medical devices)
- Dermal and respiratory sensitization hazard and risk assessment
- Preparation and submission of regulatory filings (e.g., IND, DMF)
- Evaluation of clinical trial and observational epidemiology data
- FDA/EMA regulatory negotiations
- Risk communication
- Recall and Litigation support