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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Comprehensive toxicology services
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.
We offer global solutions covering the entire product lifecycle
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:
- 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
- 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)
- 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
- GHS classification
- Safety Data Sheet (SDS) or Material
- Safety Data Sheet (MSDS) authoring
Clinical Development Services
PharmaLex provides global Clinical Development / Clinical Regulatory expertise to support every step of the clinical development pathway, from first in man studies through registration studies as well as post approval programs. This includes software for management of trial master files, resources for day-to-day processing of trial content and associated expert consultancy through one of the PharmaLex family of companies.More Info
Clinical Trial Applications
PharmaLex provides support for all aspects of Clinical Trial Authorisation (CTA) and Investigational New Drug (IND) applications and, with clinical regulations continuing to evolve around the world, it is more important than ever to have the right expertise by your side.More Info
Our comprehensive approach meets the holistic needs of start-ups, venture capital funded firms and small to mid-size biotech companies, while our targeted expertise helps large pharmaceutical companies with specialized development strategies needed.More Info
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