Monitoring live
For pharma companies & CROs

Legislation monitoring you can prove to an auditor.

VigiEye watches EMA, the European Commission, 18 EU national medicines agencies, MHRA and FDA for regulatory, pharmacovigilance and clinical-trial changes. Every change in your scope is summarised, linked to its official source and kept in a dated monitoring record you can export for audits, sponsor qualifications and inspections.

Enterprise licences for pharma companies and CROs · Pro from €249 per user per month for individual RA and PV professionals

GVP & pharmacovigilance
CTR & ICH GCP
Source-linked every item
Exportable monitoring record
Who it's for

For organisations that have to show they watch the rules

Inspectors and auditors ask the same question: how do you know when the legislation changes, and what did you do about it? VigiEye answers the first half, with evidence.

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Pharma companies

Marketing authorisation holders need documented regulatory intelligence for pharmacovigilance, labelling, quality and market access. One watch for RA, PV and QA, filtered by market and subject, with a dated record for inspections and partner audits.

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CROs

Sponsors audit how you keep up with clinical-trial, GCP and safety-reporting rules in every country you run studies. Show them a source-linked watch across EU and US authorities, and the monitoring record behind it.

✓

How you prove it

Every item is time-stamped when VigiEye captures it and linked to the official source. Export the monitoring record for any period and scope, and file it with your regulatory-surveillance SOP.

Why VigiEye

One watch across EU and US regulators

National agencies publish in their own languages, on their own websites, with no common feed. VigiEye brings them together and tells you what changed and why it matters.

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Per-country coverage

EMA, the European Commission and HMA, 18 national competent authorities, MHRA, FDA and Health Canada. Pick the markets you operate in.

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Per-subject filtering

Slice by subject: signal management, PSUR/PBRER, labelling & SmPC, GVP inspections, clinical trials (CTR), falsified medicines, and more.

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AI change summaries

Each update gets a plain-language summary of what changed and an impact flag, clearly labelled as AI, with the official document one click away.

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Daily briefing

A weekday e-mail briefing with the new approvals, safety actions, guidelines and deadlines, plus a regulatory calendar of what is coming up.

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Cited to the source

Every item links to the official publication it came from. Links to anything other than an official source are filtered out.

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Monitoring record

Export a dated CSV of every change captured in your scope for any period: capture time, source date, authority, subject, impact and the official link.

The problem

Manual regulatory watch doesn't scale

Today, without VigiEye
  • Someone checks dozens of agency websites by hand, or not at all
  • Updates arrive in many languages with no summary of what changed
  • Relevant changes get missed; you find out at inspection
  • No record proving you actually monitored the landscape
With VigiEye
  • VigiEye continuously watches every source for you
  • AI summarises each change in English, with an impact flag
  • Filtered to your countries, subjects and product portfolio
  • Every item cited to source, time-stamped and exportable as a monitoring record
How it works

From dozens of agencies to one prioritised feed

Set it up once. VigiEye does the watching, summarising and prioritising continuously.

Choose your scope

Select the markets and the subjects your SOP says you must watch.

We monitor the sources

VigiEye checks EMA, the European Commission, HMA, the national agencies, MHRA and FDA every two hours.

AI summarises & flags

Each change gets a plain-language summary, effective date and impact rating, cited to source.

You keep the evidence

A daily briefing, a filtered workspace, and a monitoring record you can export for any period.

Coverage

EU, UK and US sources, one taxonomy

Every level of the European medicines landscape, mapped to a consistent country × subject grid.

Countries & authorities

EU level, 18 national authorities, UK and US
EU · EMA · European Commission · HMA/CMDh
🇩🇪 BfArM / PEI
🇫🇷 ANSM
🇪🇸 AEMPS
🇮🇹 AIFA
🇳🇱 IGJ
🇬🇷 EOF
🇦🇹 BASG
🇵🇹 INFARMED
🇬🇧 MHRA
🇺🇸 FDA
+ 10 more EU agencies

Subjects

The pharmacovigilance & regulatory taxonomy
Signal management
PSUR / PBRER
Labelling & SmPC
GVP modules
Clinical trials (CTR)
Falsified medicines
RMP & PASS
Shortages & recalls
Fees & guidance
Free · EU regulatory calendar

What's coming up in EU regulation

EMA committee meetings, MDR/IVDR and HTA milestones, guideline and consultation deadlines, each linked to its official source. See the full calendar →

Pricing

Plans for professionals, companies and enterprises

Individual plans start today. Company and enterprise licences come with onboarding to your surveillance procedure.

Pro · for individuals
€249
per user / month
  • All covered authorities
  • All subjects
  • Daily e-mail briefing
  • AI summaries & impact flags
  • Monitoring record export
Company
€199
per user / month · billed annually
  • Everything in Pro
  • For RA, PV and QA teams
  • Monitoring record for audits and inspections
  • Annual invoice for procurement
Enterprise · pharma & CROs
Custom
organisation-wide licence
  • All users in your organisation
  • Onboarding to your surveillance SOP
  • Support for your supplier qualification audit
  • Extra sources on request
  • Named contact and service levels in contract
Talk to us

Show your auditor what you monitor, and when.

Tell us your markets and subjects, and we will set up a trial of your watch and its monitoring record.

Book a demo