EMA ERA Decision Tree & Navigator
Interactive decision-support tool for navigating Phase I and PBT/vPvB ERA pathways.
Pharmaceutical Environmental Risk Assessment • Regulatory Toxicology
ToxWriter — Pharmaceutical Environmental Risk Assessment (ERA)
Project-focused pharmaceutical ERA for human medicinal products, alongside PDE / ADE, OEL / OEB and regulatory toxicology support.
Core capabilities
Three specialist workstreams, one scientific approach.
Clear toxicological reasoning, regulatory context and disciplined documentation across environmental and human-health exposure questions.
ERA
Environmental Risk Assessment
Assessment of environmental exposure and potential risk from the use of human medicinal products, structured around the current regulatory framework and the active substance.
PDEPDE / ADE
Health-based exposure limit assessments that review pharmacology, toxicology, critical effects, points of departure and uncertainty considerations.
OELOEL / OEB
Occupational exposure assessments focused on worker protection, airborne exposure limits, exposure bands and the link between toxicology and industrial hygiene.
ToxWriter pharmaceutical ERA
Environmental Risk Assessment support for human medicinal products.
ToxWriter supports pharmaceutical ERA from initial exposure screening through Phase II, environmental risk characterisation and relevant PBT/vPvB assessment. The work is aligned to the intended regulatory market and the evidence available for the active substance.
PHASE I
Exposure screening
Review the active substance, use context, maximum daily dose and relevant exposure inputs, including PECSW and FPEN considerations.
PHASE IIFate, effects & risk characterisation
Where triggered, support environmental fate and ecotoxicity evaluation and PEC/PNEC-based risk characterisation.
PBTPBT/vPvB & data strategy
Assess relevant persistence, bioaccumulation and toxicity considerations and identify environmental data and access requirements for the submission.
Looking for a substance that is not yet listed? ToxWriter can also review custom ERA requirements for active substances outside the profile directory. Discuss your substance →
How we work
From regulatory question to usable documentation.
01
Define the question
Substance, product, route, intended market and submission context are established before scope is fixed.
02
Review the evidence
Available regulatory, literature, pharmacological, toxicological and environmental evidence is evaluated for relevance and reliability.
03
Deliver the assessment
The agreed assessment is translated into structured scientific documentation with clear rationale and traceable scope.
Directory
ERA profiles
Search the active-substance ERA directory. Profile pages do not publish confidential study results or report files.
Directory
PDE profiles
Search the PDE / ADE profile directory and request project-specific scope and applicability.
Directory
OEL profiles
Search the occupational exposure profile directory and request project-specific support.
Regulatory knowledge hub
Practical guidance on pharmaceutical and product-safety requirements.
Explore regulatory concepts before requesting a project-specific assessment. These background pages link to official guidance and explain ToxWriter service areas.
Pharmaceutical ERA: Phase I and Phase II
How the environmental assessment progresses from environmental exposure screening to further fate, effects and risk characterisation.
EU and UK pharmaceutical ERA
How the current EMA framework relates to UK ERA submissions and UK prevalence considerations.
PECSW and FPEN in ERA
Why population fraction and treatment context can affect the Phase I environmental exposure estimate.
PDE / ADE methodology
How a health-based exposure limit is derived from pharmacology, toxicology, a point of departure and adjustment factors.
OEL / OEB / OHC
How workplace exposure limits and exposure bands fit into occupational risk management.
ERA vs PDE vs OEL
A practical comparison of three distinct regulatory and occupational exposure concepts.
Pharmaceutical impurity risk assessment
How ICH M7 and Q3A/Q3B frameworks inform impurity identification, qualification and control.
Cosmetic Product Safety Report (CPSR)
EU and Great Britain CPSR preparation, cosmetic safety assessment and the Product Information File.
Start a project
Send the API, product and market.
We will review the requested scope and confirm the appropriate assessment pathway, information needs and next step.