Regulatory Toxicology • Pharmaceutical ERA • PDE • OEL info@toxwriter.com

Pharmaceutical Environmental Risk Assessment & Regulatory Toxicology

ToxWriter provides Environmental Risk Assessment and regulatory toxicology support for pharmaceutical products, with a focus on EU and UK requirements.

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Specialised toxicology and regulatory safety support

Whether the product is a drug, medical device, cosmetic, consumer product, or food ingredient, ToxWriter provides scientific toxicological risk-assessment and regulatory support.

Environmental Risk Assessment

Phase I and Phase II ERA, data gaps, testing strategy, PEC/PNEC considerations and regulatory-ready reporting.

Regulatory Toxicology

ICH M7, impurity assessment, genotoxicity, QSAR, PDE/ADE, OEL, OEB and OHC support.

Scientific Writing and Product Safety

CTD/eCTD writing, cosmetics safety, biocompatibility and extractables and leachables assessment.