Workflow design and AI-enabled support for regulatory toxicology — built around the questions an evaluator asks, the validation evidence the file needs, and the boundary between automated outputs and expert judgement.
Workflows where the toxicology and the automation are designed together — not separately.
Most off-the-shelf tools exist for regulatory toxicology tasks. The value lies in how they are integrated, validated, and aligned with the regulatory question the workflow is meant to address. We design digital workflows for regulatory toxicology drawing on direct experience of authority scrutiny — and deliver implementation through established technology partners selected for each engagement. NexGenTox defines what the workflow needs to produce, where automation adds value, where expert review stays, and how the validation is documented. Implementation partners bring the development, data engineering, and platform capability to build solutions that hold up under both regulatory and technical review.
Workflow design and validation led by regulatory toxicologists; implementation delivered with established technology partners holding ISO 27001 / SOC2 certifications.
Across the regulatory toxicology workflow, from data structuring to governance — developed in collaboration with our technology partners.
From substance portfolio databases to screening workflows — automation aligned with the regulatory question.
Regulatory teams whose substance portfolio has outgrown spreadsheet tracking. Toxicology teams rebuilding literature screening logs each renewal cycle. R&D groups screening candidate substances against hazard criteria ahead of testing. Companies running recurring evidence compilation across multiple substances and submissions.
A regulatory toxicology team was preparing the CLP classification argument for a substance flagged for STOT RE (specific target organ toxicity, repeated exposure) based on findings at high dose levels. The team's position was that the effects were secondary to systemic toxicity at exposures unlikely to occur in realistic use, and that the substance should not warrant STOT RE classification. Building the argument required showing that the regulatory community had reached similar conclusions for structurally and toxicologically related substances.
Each classification argument needed cross-substance precedent — but manual data extraction across ECHA's harmonised classification database, CLP Annex VI, and dossier-level data was time-intensive and inconsistent. Each substance assessment involved repeating the same extraction work across the same sources, with no structured record of what the team had already learned about the pattern of classification decisions in this chemical space.
Outcome. A workflow that surfaces the regulatory classification trend across substance cohorts in a single structured output, replacing manual data extraction. For the case substance, the structured trend analysis provided cross-substance precedent supporting the classification waiver argument. The workflow has since been re-run for other substances in the team's portfolio facing similar classification questions.
Five questions that come up early in most digital workflow engagements. If yours doesn't fit, send it through anyway — we'd rather hear the question than guess at it.
In high-volume, repetitive tasks where structure and traceability matter more than judgement at each step — literature collation, evidence tracking, data compilation, and template-based summarisation. Less value in tasks where the regulatory question is genuinely complex and requires expert interpretation at each step.
Through documented validation, version control, audit trails, and clear scope-of-use documentation for each tool. Computational outputs are integrated into the assessment with expert review, and the boundary between automated outputs and expert decisions is recorded.
Both. NexGenTox defines the workflow's regulatory purpose, the data structure, the validation expectations, and the expert decision boundaries. The implementation partner brings the development, data engineering, and platform capability to build the system. The toxicology and the technical build are designed together from the start.
Implementation partners are selected for ISO 27001 and SOC2 conformances and other relevant certifications appropriate to the engagement. Confidentiality, access control, and data handling arrangements are documented as part of the workflow design, with NexGenTox retaining oversight of the regulatory toxicology data flow.
Yes. Workflows are handed over with the documentation and training the client's team needs to run them effectively — covering version control, decision boundaries between automated and expert steps, and the operational SOPs the team will rely on. Implementation partners contribute training on the technical layer where needed.
Tell us the workflow under pressure, the data volumes involved, and the regulatory context. We'll come back with an initial scope and a fit assessment.