The AI pharmacovigilance platform for pharma SMEs and biotechs who cannot afford a missed deadline or a coding error to jeopardise their MA. NLP extraction · MedDRA AI coding · CIOMS I & E2B(R3) · 6 authorities.
No changes to your existing infrastructure. No safety database required to get started. Operational in 15 minutes.
Forward your notification emails to your dedicated PharmaVeil address, upload a scanned CIOMS I form, or use our integrated web form.
Email · PDF · Web formOur NLP agent identifies the 4 mandatory GVP elements (patient, reporter, drug, effect), suggests the MedDRA term with a confidence score and calculates the regulatory deadline.
NLP + LLM + MedDRA 27.0You review the pre-filled form field by field (colour-coded confidence), edit if necessary and validate. The CIOMS I PDF report is generated with a full audit trail.
CIOMS I · E2B(R3) · Audit trailEvery feature was co-built with active QPPVs and Drug Safety Officers. No unnecessary features. Only what a PV team needs every day.
Reads and extracts data from emails, scanned PDFs and forms. Optimised for French and English. German and Spanish planned Q4 2026.
FR · EN DE · ES Q4 2026PT/LLT term suggestions with confidence score. MedDRA 27.0 dictionary integrated. Colour code: green (high confidence), orange (to review). 1-click validation.
MedDRA 27.0 · Score confianceAutomatic 7/15/90-day deadline calculation based on case seriousness at intake. Real-time deadline and backlog dashboard. Automatic D-3 and D-1 email alerts sent to the QPPV. Zero serious cases missed.
GVP Module VI · 7/15/90d · Email D-3/D-1Signed CIOMS I PDF report ready to submit. E2B(R3) XML natively adapted for 6 authorities: EudraVigilance (EMA), MHRA-YC (UK), Health Canada Vigilance, ANSM, FDA/FAERS and SAHPRA. Electronic signature 21 CFR Part 11 compliant.
CIOMS I · E2B(R3) · 6 authoritiesSmart deduplication algorithm on patient + drug + effect + time window (Claude AI). Visual banner before validation if a potential duplicate is detected, with direct link to the similar case. On-demand re-check available.
Claude AI · Visual bannerReal-time view of backlog, current deadlines and compliance rate. Full audit trail compliant with 21 CFR Part 11. Exportable for your PSMF and inspections.
PSMF · 21 CFR Part 11PharmaVeil doesn't stop at data collection. The platform integrates the scientific tools a QPPV uses every day — causality assessment, interaction management, patient history, automatic follow-up letters and signal detection.
Naranjo algorithm (10 questions, score auto-calculated) and WHO-UMC scale in parallel. Automatic classification: definite, probable, possible, doubtful. Q9 pre-filled from the patient's medical history.
Naranjo · WHO-UMCAutomatic NLP extraction of co-medications from the narrative. Built-in drug interaction database. Visual alerts before validation when a critical interaction is detected. E2B(R3) export automatically updated.
NLP · Interaction databaseManual entry or NLP extraction of medical history, allergies and concurrent conditions. Auto-feeds Naranjo Q9. Compliant with ICH E2B(R3) section B.2 — ready for export.
Section B.2 · NLP extractionAutomatic detection of missing E2B fields. PDF generation for 4 letter types (initial, D+7, D+14, escalation) with daily cron. No more forgotten incomplete cases — the system chases reporters for you.
Auto PDF · Cron D+0/D+7/D+14Pharmacovigilance signal management module and aggregated line listings by INN, MedDRA PT or time period. "Self-reporter" toggle for self-reported cases. Supports EMA proactive signal detection requirements.
Signal management · ListingsReal-time RSS feeds from 4 authorities (MHRA, FDA, ANSM, SAHPRA) digested daily by AI. Filtering by client profile (INN, country, vigilance type). No need to manually monitor 30 regulatory websites.
MHRA · FDA · ANSM · SAHPRABased on an average hourly cost of €65/h for a Drug Safety Officer profile and 70 min of manual processing per case per TransCelerate benchmarks.
* Indicative calculation: 90 sec/case with PharmaVeil vs indicated manual time. Includes Pro subscription at €1,499/month. Excludes savings on regulatory penalties and reduced error risk.
Pharmacovigilance handles sensitive health data. PharmaVeil was architected from the ground up to meet the requirements of auditors, inspectors and QPPVs globally.
Your pharmacovigilance data is health data under GDPR. It is hosted exclusively on HDS-certified servers in France within the European Union.
PharmaVeil is designed to integrate into your validated quality system. We provide the documentation your QA team needs for system qualification.
Each PharmaVeil client has a fully isolated environment. Your data is never shared or used to train global AI models.
PharmaVeil's AI never submits a case autonomously. Every MedDRA coding decision and every submission requires explicit human validation — in line with CIOMS WG XIV recommendations (2024).
"PharmaVeil solves exactly the daily problem of small PV teams: too many cases, not enough resources, relentless regulatory deadlines. The demo on our own cases convinced us in 20 minutes."
"The MedDRA suggestion with confidence score is exactly what I was looking for. It doesn't replace the coder's expertise — it enhances it and reduces lookup time by 80%."
"The PSMF-ready dashboard transformed our audit preparations. What used to take a full day of compilation now takes 10 minutes. The audit trail is exactly what inspectors expect."
Unlike most players, PharmaVeil charges a flat monthly subscription. Your cost never fluctuates with your case volume.
"With PharmaVeil Pro, you address the 3 mandatory signal detection sources required by the EMA: spontaneous reports (Core PV) ✓, unstructured incoming flows (OCR+NLP) ✓, and scientific literature (MLM Screening — manual import today, multi-source automation Q4 2026). At your next inspection, your process is traced, logged and auditable in a single platform."
During the demo (45 min, video call), we process one or more of your real anonymised cases live. You immediately see the value on your own content.
We will contact you within 24 business hours to schedule
your personalised demo.
In the meantime, if you have any urgent questions:
[email protected]