Structured literature searches, evidence mapping, and reliability-scored evidence integration — built so an evaluator can verify the search, follow the inclusion logic, and rebuild the conclusion from the same inputs.
A literature file a regulator can rebuild — not just read.
Most literature failures aren't about the conclusion. They're about traceability. An evaluator opens a literature file and asks four things: was the question framed precisely; were the right databases queried with documented syntax; were inclusion and exclusion calls applied consistently; and is each cited study weighted in line with its actual reliability. Our reviews are built so each of those is answerable from the file itself.
From question to conclusion — every step documented, every call evidenced, every weighting reasoned.
Across the literature lifecycle, from regulatory question to integrated evidence.
From regulatory question to integrated evidence — one documented base, reproducible across renewals.
Registrants whose existing literature review has been challenged for traceability or weighting. Active substance dossiers requiring full literature coverage across human health and environmental endpoints for BPR or PPP submission. Read-across justifications where source-substance literature needs systematic evaluation before integration into the dossier. Consortia building shared evidence bases that need to support multiple submissions and renewal cycles.
An active substance approaching BPR renewal required a comprehensive systematic literature search across all human health and environmental endpoints, covering accumulated published literature since the previous review cycle. The renewal dossier needed traceable evidence identification, reliability-scored study summaries, and structured evidence tables ready for integration into the dRAR.
Over a decade of accumulated published literature across multiple endpoint groups — repeated-dose toxicity, reproductive and developmental toxicity, genotoxicity, carcinogenicity, endocrine endpoints, and ecotoxicity — with mixed study quality, varying relevance to the regulatory question, and a previous review cycle that had not provided sufficient documentation for re-execution at renewal.
A reproducible SLR covering all relevant endpoint groups, with documented protocols, search strings, screening decisions, reliability assessments, and evidence tables. The evidence base was structured so each inclusion and weighting call could be verified from the file, and search protocols documented so the SLR can be re-executed at the next renewal cycle.
Five questions that come up early in most literature engagements. If yours doesn't fit, send it through anyway — we'd rather hear the question than guess at it.
An SLR has a documented protocol — question, search syntax, screening criteria, and reliability assessment defined in advance and applied consistently. A narrative review summarises selected studies without that traceability.
For regulatory contexts where the evaluator needs to verify the search, an SLR is the standard expected.
Endpoint and framework dependent. We default to Klimisch and ToxRTool for mammalian toxicology, CRED for ecotoxicity, and SciRAP or the NTP/OHAT approach where the regulatory framework or endpoint cites them. Reasoning is documented per study rather than assigned by default.
Yes. Regulatory grey literature — agency assessment reports, scientific committee opinions, monographs, and authority guidance — is included where relevant to the regulatory question. Sources and search dates are documented alongside peer-reviewed databases.
Yes. We design search protocols so they can be re-executed periodically — supporting renewal, post-approval variations, and emerging-data reviews from the same documented evidence base.
Yes. Source-substance literature searches and reliability-scored study summaries support read-across documentation under the RAAF, with evidence tables structured for integration into the read-across hypothesis and justification.
Tell us the substance, the endpoint, and the regulatory clock. We'll come back with an initial scope and a fit assessment.