Gradient

Regulatory Compliance

Pharmaceuticals

Overview
Example Projects
Experts

Overview

Gradient assists the pharmaceutical industry with our broad experience related to the environmental and mammalian toxicology of pharmaceutical compounds. Our environmental scientists have extensive expertise in the evaluation of pharmaceuticals in the environment, new regulatory requirements, environmental safety testing, and assessment to support regulatory submissions. In addition, we provide pharmaceutical and illicit drug forensic services, such as evaluating the potential role of exogenous compounds in causing death, disease, or disability.

Pharmeceuticals

 

Example Projects

Drug Registration Environmental Assessments

Full Description

Gradient conducted several regulatory environmental assessments, compliant with FDA and EMA requirements, for a wide range of active pharmaceutical ingredients from relatively low toxicity to endocrine-active compounds. We designed and oversaw required environmental fate and toxicity testing and prepared the environmental assessment reports.

Deriving Predicted No Effect Concentrations for Pharmaceutical Ingredients

Full Description

As an integral component of new drug regulatory approval, Gradient developed an approach for developing Predicted No Effect Concentrations (PNECs) for pharmaceutical ingredients with limited available environmental data. We reviewed an extensive dataset of Active Pharmaceutical Ingredients (APIs) and developed a streamlined, environmentally protective approach for estimating PNECs for APIs when little environmental toxicity data are available.

Critique of Proposed EU Pharmaceutical Environmental Assessment Requirements

Full Description

Gradient provided comments on the EU-proposed pharmaceutical environmental assessment requirements. We recommended a streamlined, scientifically sound, tiered fate-and-effects data collection and assessment program.

Experts

Tom A. Lewandowski Read Bio

Manu Sharma Read Bio

Tim Verslycke Read Bio