Toxicological Services and Risk Assessment
Any chemical can be harmful to the human body (hazardous) when the dose (exposure) is sufficiently high. However, when you put the hazard data into 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 services and risk assessment. It is a regulatory expectation that such an assessment is performed by toxicologists who possess adequate educational qualifications and experience.
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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 rigorous regulatory scrutiny and reach the market. We achieve this by fully leveraging the data existing in the literature by way of a 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 the ‘lean study design’ concept that gives maximum safety/toxicity information and we keep the end in mind such that they generated 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.
Our solutions, consisting of core services, which are tailored to address each of your unique requirements. Extensive program management expertise is a key success factor within our service solutions.
Our toxicological risk assessment services include:
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
Cosmetics:
- Evaluation of cosmetic ingredients/products and derivation of margin of safety
- Assessment of fragrances and flavours
- Qualification of impurities
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)
Ecotoxicology and environmental risk assessment (ERA)
- ERA for generic pharmaceuticals and innovative products (CTD Module 1.6)
Medical devices:
- Biocompatibility risk assessment
- Biocompatibility evaluation plan
- Biocompatibility evaluation report
- Designing of biocompatibility studies as per ISO 10993 and ISO 18562
Food and consumer products
- Food contact materials/food additive evaluation
- Toxicological evaluation of consumer products/ingredients, including hand sanitisers and antiseptics
Chemical safety:
- GHS classification
- Safety Data Sheet (SDS) or Material
- Safety Data Sheet (MSDS) authoring
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