Specialised consultancy

Defensible science. Regulator-ready files.

For chemicals, biocides, cosmetics and pharmaceuticals — where traditional toxicological judgement meets the considered application of New Approach Methodologies.

Explore services → Meet the founders
Senior-led · End-to-end The toxicologist who scopes your project is the one who signs it.
A point of view

Most regulatory submissions fail not because the data is missing — but because the argument isn't built for the reviewer who has to defend it.

We design every assessment around the regulatory decision context. Evidence, methodology, and uncertainty aligned to the specific question your dossier has to answer — and traceable from end to end.

That's what defensibility looks like in practice.

Read our approach →
Sectors

The frameworks shift. The science doesn't.

Cross-sector experience means principles transfer cleanly between regulatory contexts — and exposes gaps before regulators do.

01 / Industrial chemicals

REACH dossiers, defended.

Registration, classification, exposure scenarios — and the substantive defence of authority queries when the evaluation arrives.

REACHCLPPBTED
See chemicals work →
02 / Biocides & pest control

BPR renewals, without surprises.

Active substance approvals, product authorisation under Article 19, and the technical equivalence work that holds renewals together.

BPR Art. 6BPR Art. 19PT 1–22
See biocides work →
03 / Cosmetics & personal care

Safety files that support the claim.

CPSR authorship, SCCS-aligned read-across and a defensible scientific narrative for the claims your product is built around.

CPSRSCCSClaims
See cosmetics work →
04 / Pharma & medical devices

Impurity limits and biological evaluation.

ICH M7 (Q)SAR assessments, PDE derivations, extractables & leachables, and ISO 10993 biological evaluation strategies.

ICH M7PDEE&LISO 10993
See pharma work →
Services

Ten disciplines. One scientific standard.

Strategy, data evaluation, dossier authoring and authority defence — across the substance lifecycle and across frameworks. Each engagement led and signed off by the toxicologist accountable for it.

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01

REACH & CLP

Registration dossiers, exposure scenarios, hazard classification — and the defence of authority queries that follow.
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02

Biocides (BPR)

Active substance approval & product authorisation.
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03

Cosmetics safety

CPSR Part A+B · SCCS-style review.
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04

Pharma & medical-device tox

PDE / OEL · Nitrosamines · ICH M7 · ISO 10993.
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05

Environmental risk assessment

PBT · vPvB · ERA modelling.
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06

NAMs & NGRA

QSAR · Read-across · AOP-anchored WoE.
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07

Endocrine assessment

EATS modalities · WoE · defence.
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08

Literature & evidence

Systematic review · evidence maps.
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09

CRO & study oversight

Qualification · audit · oversight.
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10

Digital & AI tox

In silico · ML · knowledge graphs.
All services →
Why clients return
"Their dossiers read like the reviewer wrote them. Every uncertainty is named. Every choice is justified. Authority queries fall away."
Head of Regulatory Affairs · specialty chemicals manufacturer
25+
years of combined regulatory toxicology practice
6
regulatory frameworks covered end-to-end
100%
work led & signed off by named senior toxicologist
0
junior-only deliverables. ever.
In-house tools

Free utilities, built by the people who use them.

When a calculation comes up often enough that a spreadsheet won't do, we publish a tool. Free, no sign-up, methodology open.

Calculator

PDE / OEL Calculator

Permitted Daily Exposure and Occupational Exposure Limit derivation aligned with EMA HBEL guidance and ICH Q3D.

EMA · ICH Q3DOpen →
N–N=O
AI screening

Nitrosamine AI

Structural alerts and CPCA category prediction for nitrosamine impurities — ICH M7(R2) aligned, with reasoning shown.

ICH M7(R2) · CPCAOpen →
Screening

ED Screening

Endocrine disruptor screening across the EU criteria — modality, mode of action, evidence summary export.

EFSA / ECHA criteriaOpen →
Assessment

PBT / vPvB Assessment

Persistence, bioaccumulation and toxicity weighting against REACH Annex XIII — with documented justifications.

REACH Annex XIIIOpen →
Insights

Notes from the practice.

Plain-language briefings on what's actually changing in regulatory toxicology — and what it means for substances on your bench.

REACH·9 min read

REACH 2025: what the revision actually changes for registrants
NAMs·12 min read

NAMs are not a replacement strategy. They're an evidence strategy.
ED Assessment·7 min read

Endocrine disruption: a practical guide to building a defensible weight of evidence
All insights →
Start a conversation

Bring us a hard regulatory question.

We're at our best when the path forward isn't obvious — when read-across is contested, classification is borderline, or the data argues against itself. Tell us what you're up against.

Email the founders →