Toxicological Risk Assessment Centre of Excellence (TRACE)

Toxicological support specializing in product safety and occupational toxicology to pharmaceutical, biotechnology, and medical device companies worldwide.

Qualitative and Quantitative Health Assessments are an integral part of product development, manufacturing, and post-marketing surveillance. The process can be challenging, as it requires knowledge of the latest regulatory expectations (i.e., ICH, FDA, EMA, WHO). Product safety guidelines require establishment of safe levels for risk of cross-product contamination in multi-product facilities, extractables and leachables, mutagenic and non-mutagenic impurities, particle contamination, and volatile organic compounds. Furthermore, regulatory agencies require that excipients, degradants, contaminants, and residual solvents are present at levels that are scientifically justified and supported. To establish these safe levels, Health-Based Exposure Limits (HBELs) such as an acceptable daily exposure (ADE) [also known as permitted daily exposure (PDE)] may be established, while other qualitative assessments also may be needed (e.g., mutagenic impurity classification as per ICH M7 methodology), all of which are required to be performed by qualified, experienced, and board-certified toxicologists.

Occupational toxicology assessments involve hazard identification and establishment of an occupational exposure limit (OEL). During early drug development stages, when information on the active pharmaceutical ingredient is limited, a preliminary categorization and placement of the active pharmaceutical ingredient into a control band can be performed.

Intertek is a global leader in hazard identification and risk assessment through our understanding of the complex regulations and by providing comprehensive solutions for our clients. Total quality assured culture is key to all aspects of our work, professional training, and client relations. Our senior staff have extensive technical training, board-certification credentials, and decades of cumulative experience.

We can provide product safety and occupational toxicology assessments to support the R&D and manufacture of compounds in the pharmaceutical, biotechnology, and medical device industries.

Our core services include:

  • Permitted daily exposure (PDE) calculation
  • Excipient qualification
  • Impurity assessment and qualification
  • Extractables and leachables assessments (drugs and medical devices)
  • Volatile organic compounds assessments (medical devices)
  • Particle contaminant assessments
  • F-value calculation for childproof packaging
  • Occupational exposure band (OEB) assignment
  • Occupational exposure limit (OEL) calculation
  • Acceptable surface limit (ASL) calculation
  • ICH M7-compliant mutagenicity assessments including in silico evaluation
  • Nitrosamine assessment of active pharmaceutical ingredient and drug product 
  • Literature searches
  • Authoring of literature reviews
  • Authoring of white papers
  • Authoring of expert reports
Need help or have a question? +1 877 274 0181

Need help or have a question?

+1 877 274 0181
+86 (22) 83712202
+82 (0)2 2109 1250
+91 8291049593
0800 5855888
+49 711 27311 152
+31 88 126 8888
Wilton UK:
+44 1642 435 788
+46 8 750 00 00