Regulatory toxicology and risk assessment support for EU and UK REACH and CLP — evaluation-ready dossiers with robust hazard and risk assessments aligned to regulatory expectations.
Built around how dossiers are evaluated — not just how they are prepared.
Our work is designed to anticipate the questions an ECHA evaluator will ask. Read-across justification. Point-of-departure selection. Uncertainty handling. The internal consistency between hazard, exposure and risk characterisation. The technical reasoning is structured to hold under evaluation — not just to meet the submission template.
Testing is recommended only where regulatory expectations cannot be met through defensible alternatives.
From obligation triage at first market entry through to defence at compliance check — concrete points across the REACH lifecycle where senior input shapes the file.
The same reasoning, from data-gap analysis to PBT/PMT — structured to hold under scrutiny.
An open PBT and PMT screening tool built against REACH Annex XIII, ECHA R.11 and the 2023 CLP hazard classes — transparent criteria, traceable output.
Registrants facing a compliance check with read-across, DNEL or PBT/PMT queries on the file. Manufacturers and importers entering the EU market who need inquiry, registration and Only Representative structuring. Substances on CoRAP where evaluation has surfaced endpoint-specific concerns. Companies preparing CLH dossiers, SVHC identification or Annex XV restriction work. We also support clients bridging EU REACH obligations into GB REACH.
A ≥1000 tpa substance was selected for ECHA compliance check. Concerns were raised on the read-across justification for repeated-dose toxicity and on the derivation of the long-term worker DNEL.
A read-across justification queried on structural similarity and target-organ concordance, a long-term worker DNEL the rapporteur did not accept on its point-of-departure rationale, and a compliance-check clock running.
Outcome. Strengthened read-across justification with improved biological plausibility. Consistent and defensible DNEL derivation. Defence package prepared for member-state consultation.
The first calls usually start in one of these places. If yours doesn't, send it through anyway — we'd rather hear the question than guess at it.
Most engagements start with one question. The right answer often shapes the whole programme.
If you manufacture outside the EU, registration must be handled by an EU importer or an Only Representative. An inquiry dossier is required before registration to identify existing registrants and data-sharing obligations.
We help define the appropriate regulatory structure and prepare the inquiry and registration dossiers — so you enter the market with the right instrument and the right co-registrant relationships in place.
We review the decision, assess the scientific basis of the concerns raised, and develop a structured response strategy. This may involve strengthening justifications, refining DNEL / PNEC derivation, or advising on proportionate testing strategies — all delivered within the regulatory clock.
We first evaluate whether data gaps can be addressed through read-across, weight of evidence, literature strengthening, or refinement. Testing is recommended only where regulatory expectations cannot be met through defensible alternatives.
Yes. We support CRO qualification, protocol review, scientific monitoring, and report verification — to ensure data are GLP-compliant and suitable for inclusion in IUCLID and the CSR.
Tell us the substance, the deadline, and the authority on the other side. We'll come back with a path within two working days.
