For drug safety and pharmacovigilance leaders
Your safety experts should assess the benefit-risk balance, not compile the report.
Periodic reports pull from line listings, exposure data, literature and earlier cycles. AriaFlow assembles that evidence into a structured draft in your template, with every statement linked to its source and every gap marked. Your safety physicians focus on evaluation and conclusions.
PBRER · Section 16.3 · 16.3 Evaluation of new information on hepatotoxicity
During the reporting interval, 14 serious hepatic events were reported, compared with 9 in the previous interval SRC-03 · Line listing p.12. Estimated patient exposure increased by 22% over the same period SRC-01 · Exposure data Q2.
Reporting rates remain within the range described in the current RMP SRC-07 · RMP v6.1 §2.4.
Causality assessment for two cases: Review required [MISSING] not in source set
Sample output with synthetic data.
Documents
Start with the documents your team already writes.
Periodic Benefit-Risk Evaluation Report (PBRER)
Section-by-section draft from line listings, exposure data and the previous report.
Catalog templateQuarterly Signal Tracker
Signals consolidated with their evidence and status for review.
Catalog templatePV Steering Committee Deck
A PowerPoint summary built from the same approved sources.
Catalog templateRisk Management Plans are covered by the eCTD Module 1 templates. Further pharmacovigilance templates for ICH, EU and FDA contexts are in development.
For regulatory affairs and CMC leaders
Your regulatory experts should shape the dossier, not compile it.
CTD sections draw on reports, specifications, stability data and earlier submissions. AriaFlow assembles them into structured drafts in your templates, with every statement linked to its source. Your regulatory experts focus on the strategy and the argument.
QOS · 2.3.P.5 · 2.3.P.5 Control of drug product
The release specification for the 10 mg film-coated tablet comprises appearance, identity, assay, related substances, dissolution and uniformity of dosage units SRC-04 · 3.2.P.5.1 Specification v3.
Assay and related substances are determined by a validated HPLC method SRC-06 · 3.2.P.5.3 Validation report. The limit for impurity B is 0.2% in the specification and 0.15% in the stability protocol. Review required Conflict: confirm limit
Batch analyses for the three validation batches comply with the proposed specification SRC-05 · 3.2.P.5.4 Batch data.
Sample output with synthetic data.
Documents
Start with the documents your team already writes.
eCTD Module 1
Cover letter, SmPC, package leaflet, labelling text, environmental risk assessment, Risk Management Plan.
7 catalog templateseCTD Modules 2 and 3
Quality Overall Summary, nonclinical and clinical overviews and summaries, specifications, stability summaries.
30 catalog templatesModules 4, 5 and pre-submission
Toxicity reports, CSRs, ISS/ISE, protocols, Investigator's Brochure, informed consent.
12 catalog templatesCatalog templates are starting points. Your own Word templates can be converted into working templates by the AI Builder.
For MedTech quality and regulatory leaders
Your QA/RA experts should judge the evidence, not compile the technical file.
Technical documentation draws on test reports, risk files, design inputs and clinical data across device families. AriaFlow assembles that evidence into structured summaries, links every statement to its source and surfaces conflicts between documents. Your experts decide.
V&V Summary · 4.2 · 4.2 Biocompatibility testing
Cytotoxicity testing per ISO 10993-5 showed no cytotoxic potential for the final device SRC-02 · Test report TR-118, p.4. Sensitisation testing per ISO 10993-10 was negative SRC-03 · Test report TR-121, p.2.
The patient-contact duration is stated as <24 h in the design input SRC-01 · DI-07 and as <30 days in the risk file. Review required Conflict: confirm contact duration
Irritation test results: [MISSING] not in source set
Sample output with synthetic data.
Documents
Start with the documents your team already writes.
Verification & Validation Summary
Multi-document V&V summaries across device families.
In productive useBiocompatibility and Biological Safety
Technical summaries built from test reports and the risk file.
In productive useClinical Evidence Summary
Overall clinical evidence summaries from studies and literature.
In productive useMedical Device Technical Documentation and Medical Device Reporting templates are also in the catalog.
How a sample draft works
Read the output before you decide anything.
Every sample shows the same review conventions you would work with in a pilot.
Common questions
The questions we hear from regulatory, safety and quality leaders.
Can we trust AI-written text in a regulated document?
Every section is built from retrieved evidence from your approved sources. Statements carry citations, each section shows an evidence-coverage indicator, missing information is stated and conflicting sources are surfaced for your decision. These indicators support review; they don't replace it. Qualified experts review, edit and approve, and approval gates record who approved, when and why.
You don't hold ISO 27001 or SOC 2 yet. Why should our QA accept that?
We say it openly: no third-party security certification is claimed today. Security practices are aligned with ISO 27001 principles and SOC 2 change-management controls, and both certifications are on our roadmap. Every release ships with a versioned validation pack, and your QA team is welcome to audit us.
We already have Veeva. Why add another system?
AriaFlow prepares the draft; your document management system stays the system of record. Today AriaFlow connects through its REST API and your existing middleware. A dedicated Veeva Vault connector is on the roadmap and is scoped with you if you need it.
Our data cannot leave the EU.
It doesn't have to. Choose the EU instance and your documents, derived data and audit records stay in that region, backups included. The model vendors retain no data, and customer content is never used to train or fine-tune models. A private deployment in your own tenant is also possible.
Will this replace our writers?
No. AriaFlow takes over assembly: finding, copying, reconciling and formatting. Your experts keep interpretation, review and approval. We measure success in cycle time and review rounds, not in headcount.
We don't have budget for this right now.
Start with a 4-week pilot on one or two of your document types, measured against your own baseline. If you continue, the pilot fee is credited against the first-year subscription.
Sample draft
See a first AriaFlow draft for your document type.
We prepare a sample section with synthetic data in your document type and walk you through it in a 20-minute call with the AriaFlow team and an expert from G&L Scientific and Entourage.
- A sample section with citations, evidence coverage and flagged gaps
- Built from a catalog template close to yours, or from your own template on request
- Your questions on hosting, validation and audit trail answered
Or pick a time directly: open the booking calendar