Toxicology Studies

Consulting & Study Design Support: Helps to plan which toxicology studies are required (e.g., acute, sub-chronic, genotoxicity) and compile the study protocols.
Data Management & Documentation: Manage the non-clinical data, ensure that reports meet GLP/ICH/OECD standards, prepare summary tables, toxicology narratives, integrate with regulatory structure.
eCTD Module Integration: Prepare the non-clinical safety section (e.g., Module 2.4.3, Module 4 for drugs) for submission in eCTD format.
Regulatory Strategy: Advise on global toxicology requirements (US, EU, India, etc.), help clients navigate which studies are mandatory, bridging studies, waivers, and help compile toxicology data into regulatory dossiers.
Quality & Compliance: Ensure that the toxicology data and reports used comply with GLP, OECD Principles, and the regulatory guidance relevant to the substance (pharmaceutical, device, chemical) in the target market.

Emphasise compliance: GLP, OECD guidelines, study audit readiness.
Emphasise global alignment: regulatory standards differ by region – you can help tailor.
Emphasise integration: linking toxicology data with clinical, formulation, pharmacology, and regulatory filings.
Emphasise turnaround & cost-effectiveness: Many companies outsource these services, so positioning yourself as efficient and regulatory-savvy adds value.
Emphasise transparency of reports & eCTD readiness: Your niche of eCTD publishing ties nicely into toxicology report handling.