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 all available information/data pertaining to the specific ingredient within the context of nature of 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 its intended surface contact and duration as per 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 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 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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