Our Services

Be it a drug, medical device, cosmetic, consumer product, or food ingredient, we at ToxWriters have mastered the science of toxicological risk assessment and have helped products sail through rigorous regulatory scrutiny and reach the market. 

• Risk benefit evaluation of active ingredients for the intended patient population, route and dosage form.

• Toxicological Expert Statement for impurity specification

• ICH M7 hazard assessment and qualification

• Genotoxicity evaluation using in silico QSAR tools (OECD ToolBox)

• 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)

ToxWriters develops quality documents, performs peer review and coordinates client reviews, performs quality checks, and accomplishes the project management of various Regulatory, non-clinical writing activities in both Electronic Common Technical Document (eCTD) and CTD modules

• Non-Clinical overviews and Non Clinical Summaries (eCTD Module 2.4, 2.6 & 4 ) Preparation

• Clinical overviews and Clinical Summaries (eCTD Module 2.5, 2.7 & 5) Preparation

• Gap analysis for dossiers in non-clinical part

• Assessment of fragrances and flavours

• Evaluation of cosmetic ingredients/products and derivation of margin of safety (CPSR)

With strong Pre-Clinical, Toxicology, Biomedical, and Chemistry expertise, teams at Toxwriters perform BioCompatibility advisory and report writing activities including Extractable and Leachable projects

• Biocompatibility risk assessment

• Biocompatibility evaluation plan

• Biocompatibility evaluation report