Expert consultancy in non-clinical strategy, PDE/OEL, genotoxicity, in-licensing due diligence, and regulatory defence — led by a European Registered Toxicologist with 15+ years of global experience.
Testing strategies aligned with FDA, EMA, ECHA, REACH & ANVISA guidelines
200+ reports successfully submitted. ERT-approved & regulatory-compliant
Expert assessment using VEGA & QSAR toolbox. Impurity data gap support
Genotoxicology representation in product legal defence meetings
Safety evaluation of in-licensing dossiers for informed business decisions
eCTD, CCDS, NCOs, PIF, CPSA & CPSR toxicology sections prepared
Toxexcel© is led by a PhD-qualified toxicologist registered on both the European and UK registers of toxicologists, with deep experience across global multinational pharmaceutical, chemical, and cosmetic organisations.
Toxexcel© brings deep scientific rigour and regulatory insight to every engagement. Our principal toxicologist has worked within global multinational organisations across pharmaceutical, chemical and cosmetic sectors — providing an unparalleled understanding of what regulators expect.
We have prepared and successfully submitted over 200 PDE and OEL reports to regulatory bodies worldwide. Our expertise spans non-clinical strategy, genotoxicity assessment, in-licensing due diligence, and regulatory defence — covering the full lifecycle of a product's safety dossier.
Whether you need a single report or ongoing strategic support, we tailor our approach to your regulatory requirements and timelines.
Comprehensive toxicology and regulatory consultancy — from early non-clinical strategy through to submission support and regulatory defence.
From genotoxicity to hazard classification, our consultancy spans the full range of specialist toxicology areas required for regulatory success.
We support submissions across all major international regulatory frameworks — ensuring your dossiers are compliant wherever you operate.
US Food & Drug Administration guidelines & submissions
European Medicines Agency regulatory requirements
European Chemicals Agency — REACH compliance
Q3C, Q3D, M7 and related harmonised guidelines
Toxic Substances Control Act — US EPA chemical safety
Brazilian Health Regulatory Agency submissions
Globally Harmonized System of hazard classification
EU Medical Device Regulation & ISO 10993
Whether you need a single report, a strategic review, or ongoing consultancy support, we're here to help. Reach out and we'll respond promptly.