Pharmaceutical Health and Safety 

Our American and European Board-certified toxicologists have an extensive understanding of global regulatory and quality requirements to ensure occupational, environmental, and product safety. 

Services include: 

• Risk assessment of available toxicity data for identified hazards to support Occupational Exposure Limit (OEL) derivation, Occupational Health Characterization (OHC) based on potency, and Occupational Exposure Banding (OEB) 

• Derivation of Health Based Exposure Limits (HBELs), including Permissible Daily Exposure (PDE), Acceptable Daily Exposure (ADE), and OEL values in alignment with ICH guidelines to support margin of safety calculations at the maximum daily exposure 

• Validation of manufacturing cleaning processes to ensure workers’ safety  

• Calculation of childproof packaging F-values which indicate the difficulty involved in opening pharmaceutical packaging to prevent accidental access by children 

• Preparation of Safety Data Sheets (SDS) for active ingredients, drug products, and key intermediates 

• Ecological risk assessments of the potential impact of pharmaceuticals on the environment throughout their lifecycle, in accordance with FDA and EMA guidelines for regulatory submissions