Pharmaceutical Product Toxicological Support

In recent years we have experienced a considerable increase in demand for our services from those operating in the pharmaceutical sector; our advice is regularly sought on the toxicological risks posed by non-active substances present in pharmaceuticals.

Our scientists are experts in identifying existing relevant information on toxicity and metabolism. While toxicity data may be plentiful for excipients and certain leachables, they are often insufficient or absent for impurities, making our expertise invaluable in the application of Structure Activity Relationship (SAR) considerations and the Threshold of Toxicological Concern (TTC) concepts.

We consider ourselves the regulatory professional’s ideal partner when the knowledge required goes beyond the specifics of a particular regulation or guideline into the more nuanced territory concerned with risk assessment.

Pharmaceuticals are administered by various routes including intravenous injection, by mouth, by inhalation or dermally. We are experienced in the application of available data (often generated by the oral route) to other routes of administration. Genotoxic or potentially genotoxic impurities and contaminants can pose a particular challenge to risk assessment, and we can apply EMA/ICH guidance and make best use of the TTC concept. In addition, our risk assessors are familiar with the recently developed guidelines and draft guidelines from the Product Quality Research Institute (PQRI) on extractables and leachables in drug products.


Examples of specific assessments

  • Manufacturing impurities – risk assessment of substances that arise during manufacture and are often structurally related to the active molecule. Development of arguments for proposal of Qualification Thresholds. Some impurities may be significant metabolites (and thus, under EMA guidance, be qualified).
  • Extractables/leachables – risk assessment of substances contaminating pharmaceutical products as a result of leaching from processing equipment or storage containers during production or use.
  • Excipients – risk assessment of substances included in pharmaceutical products to perform a specific technological function.
  • Actives – hazard assessments of active substances e.g. for due diligence purposes. Risk assessment of certain changes in the active molecule e.g. changes in counter ions.
  • Elemental impurities – provision of supporting information for the risk assessment / risk management of metal impurities arising in drug products from a variety of sources, in line with the ICH Q3D Guideline for Elemental Impurities (EMA, 2016; ICH, 2014).
  • Occupational controls – determinations of worker exposure controls (e.g. OELs or banding) based on toxicity data or (where data are lacking) a “read-across” approach from structurally-related compounds.
  • Expert role – acting as Expert (Non-Clinical) fulfilling responsibilities relating to assessment of non-clinical toxicity data for submissions, in line with Annex I Part I 1.4 of Directive 2003/63/EC.


Read more about our work on “Extractables and Leachables in the Pharmaceutical sector


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