We evaluate occupational and environmental health risks from manufacturing and research operations, providing clear and actionable risk communication for management, employees, regulators, and the public. Our services include product safety risk assessments, interpretation of in silico toxicology models, impurity evaluations, and recommendations for cleaning limits to protect worker and product safety.

Our team of board-certified toxicologists has developed OELs for over 2,000 pharmaceutical compounds. These scientifically based limits help safeguard workers by defining acceptable exposure levels to chemical substances and intermediates in laboratory, manufacturing, and R&D settings.

We establish safe limits for potential cross-contamination of drug products with other active substances, intermediates, solvents, and impurities. These limits (often referred to as Permitted Daily Exposures (PDEs) or Acceptable Daily Exposures (ADEs)) support compliance with health authority expectations and help ensure product integrity.

We pioneered a globally adopted compound categorization system for handling potent compounds. We assign occupational health bands based on potency and toxicity data, and recommend appropriate handling controls for various settings, including labs, pilot plants, and full-scale production.

We prepare compliant, accurate Safety Data Sheets (SDS) for active ingredients, drug products, and key intermediates. Our SDS writers, some certified as SDS Registered Professionals, ensure SDSs meet regulatory standards and provide essential protection information for workers and the environment.

Our toxicologists assess the potential for chemical leaching from packaging and processing components into drug products. We establish acceptable limits, design testing protocols when needed, and produce defensible reports that support regulatory submissions and FDA review.

We develop environmental risk assessments in support of IND, NDA, or MAA applications. These assessments align with FDA and EMA guidelines and evaluate the potential impact of pharmaceuticals on the environment throughout their lifecycle.

We analyze pharmaceutical packaging designs to ensure they meet child-resistance standards. Our evaluations focus on failure criteria (F-values), helping confirm that blister packages present sufficient deterrence to prevent accidental access by children.

When toxicity testing is necessary, we guide clients through study design and oversight to ensure scientific rigor and regulatory compliance. We help interpret study results to support worker safety, product development, and environmental responsibility.

We provide broad toxicological support across industries, including evaluations for Proposition 65 compliance, product safety, personal injury cases, pharmaceutical cleaning limits, and workers’ compensation. This is bolstered by our regulatory toxicology team for additional depth in compliance and policy guidance.