Comprehensive toxicology services
Any chemical can be harmful to human body (hazardous) when the dose (exposure) is sufficiently high. However, when you put the hazard data in to the right context of patient exposure (dose) it informs whether patient safety is unlikely to be compromised and therefore the likelihood of regulatory acceptance. This is the foundation of toxicological risk assessment. It is a regulatory expectation that such an assessment is performed by toxicologists who possess adequate educational qualification and experience.
Be it a drug, medical device, cosmetic, consumer product, or food ingredient, we at PharmaLex have mastered the science of toxicological risk assessment and have helped products sail through the rigorous regulatory scrutiny and reach market. We achieve this by fully leveraging the data existing in the literature by way of comprehensive literature search that covers a wide variety of medical and toxicological databases. When the available data is inadequate, we apply computational toxicology or quantitative structure activity (QSAR) tools (also called in silico tools), and by fully leveraging the data available for structurally and pharmacologically similar chemical (read across approach). New experiments are recommended only when it is absolutely necessary. When we design those studies, we follow ‘lean study design’ concept that gives maximum safety/toxicity information and we keep the end in mind such that the generate data is useful in addressing the issue at hand. This helps our clients save money and time and is in line with the 3R principles of animal welfare (Reduction, Replacement, and Refinement). All through the process we keep the regulatory expectations in mind so that the assessment reports are accepted in the first place without having to answer follow-up regulatory queries.
Pharmaceuticals:
- Risk benefit evaluation of active ingredients for the intended patient population, route and dosage form
- Qualification of impurities using existing data (for small molecule/peptides/proteins/vaccines)
- Toxicological Expert Statement for impurity specification
- ICH M7 hazard assessment and qualification
- Genotoxicity evaluation using in silico QSAR tools
- Nitrosamine risk assessment and derivation of acceptable intake
- Excipient evaluation and justification for the proposed limit
- Extractable and Leachable (E&L) risk assessment
Medical devices:
- Biocompatibility risk assessment
- Biocompatibility evaluation plan
- Biocompatibility evaluation report
- Designing of biocompatibility studies as per ISO 10993 and ISO 18562
Cosmetics:
- Evaluation of cosmetic ingredients/products and derivation of margin of safety
- Assessment of fragrances and flavours
- Qualification of impurities
Food and consumer products
- Food contact materials/food additive evaluation
- Toxicological evaluation of consumer products/ingredients, including hand sanitisers and antiseptics
Cross contamination risk and occupational safety:
- Permitted Daily Exposure (PDE) or Acceptable Daily Intake (ADE) in support cleaning validation (APIs and cleaning agents)
- Occupational Exposure Banding (OEB)/Occupational Health Categorisation (OHC) for drug substance intermediates and starting materials
- Occupational Exposure Limit (OEL)
Chemical safety:
- GHS classification
- Safety Data Sheet (SDS) or Material Safety Data Sheet (MSDS) authoring
Ecotoxicology and environmental risk assessment (ERA)
- ERA for generic pharmaceuticals and innovative products (CTD Module 1.6)
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What our clients say
Rina and the team were brought in to help support us during the PMCPA complaint process and subsequent audits. Their expertise and approachability made this difficult process smooth. True professionals and a pleasure to work with!
Head of Ethics and Compliance, Astellas Pharma Europe
We needed to develop our strategy and PharmaLex had exactly the experience we needed.
Senior QA Director