Specialist toxicology and regulatory support.

Focused scientific assessment and documentation for pharmaceutical, medical-device, cosmetic and related product-safety requirements.

Core scientific work

Three areas of exposure risk assessment.

ERA

Environmental Risk Assessment

For human medicinal products, the current EMA guideline describes a stepwise assessment of potential environmental risks arising from product use. It considers the active substance's use, physicochemical properties, fate and ecotoxicity, with risk and hazard assessment including PBT/vPvB considerations.

Phase I exposure screening and PECSW assessment
Phase II fate, effects and risk characterisation where required
PBT/vPvB and tailored assessment strategies for relevant substance groups
EU / UK submission-context review

Read the ERA background →

PDE

PDE / ADE

A health-based exposure limit is a substance-specific threshold derived from pharmacological and toxicological evidence. The EMA HBEL guideline describes PDE as a dose unlikely to cause an adverse effect when exposure is at or below that level every day over a lifetime.

Hazard and critical-effect review
Point-of-departure and adjustment-factor evaluation
Route-to-route considerations where relevant
Cleaning / shared-facility carryover context

Read the PDE / ADE background →

OEL

OEL / OEB / OHC

Occupational exposure limits are workplace airborne concentration limits used to help control worker exposure. Depending on the applicable framework, limits can be expressed as time-weighted averages, short-term limits or ceiling values. Exposure banding can be used when a numeric OEL is unavailable or as part of a broader control strategy. In pharmaceutical settings, OHC (Occupational Hazard Category) and OEB (Occupational Exposure Band) terminology may be used; band definitions and cut-offs are organisation-dependent.

Health-based OEL derivation
OEB / OHC banding support
Exposure and route considerations
Industrial-hygiene context and control strategy support

Read the OEL / OEB background →

Additional capability

Regulatory toxicology and scientific writing.

TOX

Regulatory Toxicology

Scientific support for impurities, genotoxicity, nitrosamines and toxicological risk questions, including ICH M7 and QSAR / OECD Toolbox-based evaluations.

DOC

Regulatory & Scientific Writing

CTD/eCTD non-clinical content, risk assessments, summaries and supporting technical documentation, including Modules 2.4, 2.5, 2.6, 2.7 and 4 where applicable.

MED

Medical Devices & Cosmetics

Scientific support for biocompatibility and extractables / leachables work under relevant ISO frameworks, together with cosmetic product safety assessment support.

Key regulatory background

EMA ERA guideline MHRA ERA guidance EMA HBEL / PDE guideline NIOSH exposure banding

Need a tailored scope?

Tell us the substance, product and market.

We can align the assessment with the intended regulatory question and available evidence.

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