Regulatory & Safety Dossiers
Periodic, evidence-heavy regulatory and safety documents - prepared with structure, traceability and review built in.
Pharmacovigilance (PV), drug safety and regulatory teams produce some of the most demanding documents in Life Sciences - aggregate reports such as the DSUR, PBRER/PSUR and PADER, signal evaluations and risk management plans: recurring, deadline-driven, and assembled from evidence spread across many systems and functions. Each cycle repeats much of the last one while demanding that everything new is found, assessed and explained.
The challenge
Where the effort goes today
Every reporting period, teams re-collect safety data, exposure figures, literature, reference safety information and regulatory actions from different owners and formats.
Large parts of each report carry forward from the previous one, yet every carried-forward statement still has to be checked against the latest evidence.
Timelines are fixed by regulation, so effort is concentrated into short windows where experienced reviewers spend time assembling rather than assessing.
What Liorta provides
Lorgani™, applied to Regulatory & Safety Dossiers.
Outcomes, not a black box: organized evidence, structured drafts, traceable content and governed review - with people making every decision that matters.
Organized source evidence
Evidence for each reporting period brought together and organized around the document it will support.
Structured first drafts
Sections prepared in the standard structure of each document type, ready for expert review rather than written from a blank page.
Traceable content
Statements remain connected to the evidence behind them, so reviewers can check and defend what the document says.
Governed review and approval
Review, revision and approval stay with qualified safety and regulatory professionals.
Use cases
Where Lorgani applies in Regulatory & Safety Dossiers
A named application is shown where one relates to the use case today. Other use cases are areas where the platform can be applied - talk to us about your priorities.
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DSUR iDossi
Development Safety Update Report - the annual review of safety information for investigational products (ICH E2F).
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PBRER / PSUR iDossi
Periodic Benefit-Risk Evaluation Report - periodic evaluation of the benefit-risk balance of a marketed product (ICH E2C(R2)).
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PADER / PAER iDossi
Periodic adverse drug experience reporting for marketed products in the United States.
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Risk Management Plan
Safety specification, pharmacovigilance plan and risk-minimisation measures, maintained over the product lifecycle.
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Signal Evaluation Report
Documenting the evidence behind a potential safety signal and its assessment, as part of signal management.
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CTD Nonclinical Overview / Summaries
Nonclinical overview and written and tabulated summaries within the Common Technical Document.
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Quality Overall Summary
The summary of chemistry, manufacturing and controls information within the Common Technical Document.
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CMC Regulatory Sections
Chemistry, manufacturing and controls content for submissions and variations.
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Regulatory Response / Health Authority Questions
Evidence-based responses to health authority questions within committed timelines.
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Regulatory Briefing Package
Briefing documents that prepare for scientific advice and health authority meetings.
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Labeling / CCDS / CCSI Assessment
Assessing core company data sheets, core safety information and product labeling against emerging evidence.
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Label Change Impact Assessment
Understanding which documents, markets and materials a labeling change affects.
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PASS / PAES Report
Reporting for post-authorisation safety and efficacy studies.
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Benefit-Risk Assessment
Structured benefit-risk documentation drawing on efficacy, safety and exposure evidence.
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Safety Narrative Generation
Case narratives for serious adverse events, adverse drug reactions and events of special interest, prepared for expert review.
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Aggregate SAE / AESI Review
Aggregate review of serious adverse events and adverse events of special interest across a programme.
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Submission Content Reuse / Country Dossier
Adapting approved core content consistently across markets and submissions.
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Inputs and outcomes
Information involved
- Previous periodic reports
- Safety databases and case listings
- Exposure and sales information
- Investigator’s Brochure and reference safety information
- Scientific literature
- Regulatory correspondence and actions
Outcomes enabled
- Reviewer-ready periodic reports
- Consistent content across related documents and markets
- Supports faster assembly against fixed regulatory timelines
- Clear evidence trails for review and inspection
Where people stay involved
Safety physicians, pharmacovigilance scientists and regulatory professionals remain the authors of record. They decide what the evidence means, review every section and approve what is submitted.
Related application
iDossi - Intelligent Dossiers
Transform heterogeneous source evidence into structured, traceable and reviewer-ready aggregate safety reports and regulatory dossiers.