Toxicology/Non-Clinical Services

Toxicological Risk Assessment (TRA) is a comprehensive safety-evaluation report for a specific ingredient or contaminant in the product. TRA is a detailed scientific assessment report prepared by an expert toxicologist based on sound scientific knowledge on the available information/data pertaining to the specific ingredient within the context of nature of the product, its dosage/concentration, and exposure scenario.

Freyr toxicologists, with their vast experience in toxicological risk assessment of pharmaceuticals, cosmetics, medical devices, food, and consumer products, have delivered numerous high quality TRA reports and non-clinical study report templates to many clients across the globe.

Freyr Expertise

Pharmaceuticals

  • Safety evaluation and assessment of pharmaceutical excipients as per intended formulation and clinical usage.
  • Clinical exposure assessment, qualification, and Regulatory support for the DP/DS impurities.
  • Integrated safety evaluation and assessment of new drugs as part of drug discovery and development.

Medical Device

  • Biocompatibility safety assessment of medical devices as per their intended surface contact and duration, based on ISO-10993.
  • Safety evaluation and Regulatory support for extractables and leachables.

Cosmetics

  • Human risk assessment and individual hazard assessment of flavours and fragrances.
  • Safety assessment of cosmetics and its individual ingredients.

Consumer Products

  • Toxicological risk assessment and exposures calculation for various consumer products viz e-cigarettes, single, and multi-component ingredients, or mixtures.

Food

  • Toxicological risk assessment of food-contact material migrants and derivation of oral TDIs.
  • Assessing the hazards of natural compounds associated with food contamination.
  • Derivation of Health Criteria Values (HCVs) for substances present in food.
  • Recommending a Tolerable Daily Intake (TDI) for a contaminating pesticide.

General Chemicals

  • Complete safety reports for the chemicals as per various regulations like the REACH.
  • GHS classification services.
  • SDS/MSDS services.

Latest Resources

  • Blogs

    ANVISA Becomes a Member of PIC/s Committee

    ANVISA Becomes a Member of PIC/s Committee

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  • White Papers

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

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  • Webinars

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner?

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What Our Clients Say?

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