Pharma Regulatory Intelligence

Regulatory intelligence

built for speed.

NoxReg monitors 55+ global health authorities — EMA, FDA, MHRA and more — delivering AI-powered importance scoring, plain-English summaries, and team-specific action recommendations the moment a guideline drops.

PSUR AutomationSignal DetectionEudraVigilancePBRER GenerationGVP ComplianceeCTD ReadinessDSUR DraftingICH E2E Alignment
0+
Global health authorities
0+
Updates indexed
<4h
Time to alert after publication
0
Regulatory categories
app.noxreg.com / dashboardLive
Signal Intelligence Dashboard
Cases reviewed
1,284
Signals flagged
17
PSUR due
3
GVP score
98%
Case volume — last 12 weeks

Trusted by PV teams at CROs, MAHs, and biotech companies across Europe

Monitoring
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+ 35 more
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4.9

Used by 140+ regulatory professionals across Europe & North America

🏭Pharma MAH🔬Global CRO💊Specialty Pharma🛡️QPPV Office📋RA Consultancy🧬Biotech Firm

The problem

Regulatory teams are drowning in updates.

EMA alone publishes dozens of documents a week. Multiply that by 55 agencies across 5 continents — and manually tracking it all becomes a full-time job. Things get missed. Deadlines slip. Recalls are flagged late.

Before NoxReg
After NoxReg
Manually checking 55+ websites every morning
Automated monitoring — zero effort, nothing missed
Miss critical recalls published out of hours
Instant alerts, <4h after publication by any agency
2h/day on agency sites for monitoring alone
10-min morning review of what actually matters
Generic email blasts with no relevance filter
Role-specific digests — PV, RA, QA get different content
No way to know which updates need action
Urgent / Important / Info auto-scored by AI on arrival

How it works

From publication to action in hours, not days.

01

We monitor 55+ agencies

Our automated intelligence engine continuously checks EMA, FDA, MHRA, ANSM and 51 other health authorities — capturing guidelines, safety notices, recalls, product approvals, and more.

02

AI classifies & summarises

Each update is scored for importance, assigned a product type and regulatory category, and summarised in two plain-English sentences your team can act on.

03

Your team gets what matters

Receive targeted digests, browse the filtered dashboard, or pull updates via API. Pro subscribers also get team-specific action recommendations for every urgent item.

Features

Everything your regulatory team needs.

From daily recall alerts to long-term compliance planning — NoxReg covers the full regulatory lifecycle with AI-powered context at every step.

AI importance scoring

Every update is automatically classified as Urgent, Important, or Informational — so you see what needs action today.

In practiceA drug recall from FDA is marked Urgent instantly. A routine ICH consultation is filed as Informational. Your Monday starts with exactly 3 items that matter.

Plain-English summaries

Each article gets a 2-sentence AI summary explaining what the update means for a pharmaceutical company — no more opening 40 tabs.

In practiceInstead of reading a 12-page EMA CHMP opinion, you see: "EMA approved a new PSUR submission window for mAbs. Companies must update their PBRER schedule by Q3."

Team action recommendations

For urgent updates, NoxReg tells you which team should act and exactly what to do — no ambiguity, no manual triage.

In practice"PV team: Review active RMPs — this MHRA update changes required signal detection frequency for high-risk products." One line. The right person knows.

Targeted email digests

Daily or weekly emails filtered by your agencies and categories. Urgent items always lead. Action recommendations included for Pro subscribers.

In practiceYour PV team gets a Monday digest with only EMA + FDA pharmacovigilance updates. Your RA team gets daily MHRA + TGA alerts. Each person sees only what matters to them.

Granular filtering & profiles

Filter by agency, category, importance level, product type, and date. Save named filter profiles for one-click views per team or project.

In practiceSave "EU Oncology" — EMA + MHRA, oncology, Urgent + Important only. Another for "Global PV" — all agencies, pharmacovigilance. Switch in one click.

REST API access

Pull updates into your own dashboards or compliance tools via a clean JSON API. Filter by importance, category, agency, and date range.

In practiceFeed NoxReg data into your Veeva Vault, SharePoint compliance board, or internal tools. Query urgent FDA updates from the last 7 days — one API call.
Regulatory intelligence expertise

We know the difference between
a PSUR and a PBRER.

NoxReg is not a generic news aggregator. It was built specifically for pharmaceutical regulatory professionals — with categories, terminology, and importance scoring designed around ICH, EMA, FDA, and global HA workflows.

Regulatory vocabulary

Categories match real-world workflows: pharmacovigilance, regulatory affairs, product approvals, clinical, GMP, and more.

Global coverage

55+ authorities across EU, US, UK, Asia-Pacific, Latin America, and the Middle East — all in one unified feed.

Action-oriented

We don't just summarise. For urgent items, NoxReg tells you which team should act and what to do — PV, RA, QA, or medical affairs.

Who it's for

Purpose-built for life sciences teams.

Whether you're a 10-person biotech or a global pharma company managing 50 markets — NoxReg scales to your portfolio.

🏭

Pharma companies

Marketing authorisation holders managing post-approval obligations, label changes, PSUR/PBRER cycles, and recall compliance across multiple markets.

🧬

Biotech firms

Early-stage and clinical-stage companies tracking guideline updates, IND/CTA requirements, and agency consultation windows that affect pipeline strategy.

🔬

CROs

Contract research organisations monitoring regulatory changes across EU, US, UK, and APAC jurisdictions on behalf of multiple sponsor portfolios simultaneously.

🛡️

Pharmacovigilance teams

Signal detection leads, QPPV offices, and PV associates tracking safety notices, recalls, RMP updates, and PSUR submission triggers from 55+ agencies.

📋

Regulatory Affairs

RA directors and associates monitoring submission deadlines, new guideline adoptions, agency Q&A documents, and variation procedures across markets.

Quality & Compliance

QA teams and compliance officers tracking GMP deficiency letters, inspection outcomes, product defects, and manufacturing authorisation changes.

Security & Compliance

Built to meet pharma's compliance standards.

NoxReg is designed for regulated pharmaceutical environments. We align with the data governance, privacy, and security expectations of GxP organisations operating in the EU and globally.

GDPR Compliant

All data is processed and stored on EU infrastructure. We collect only what is necessary, never sell subscriber data, and honour all data subject rights under GDPR.

Encrypted in Transit & at Rest

All communications use TLS 1.3. Data at rest is encrypted via AES-256. API keys are stored as one-way SHA-256 hashes — even we cannot read them.

GxP-Aware Intelligence

AI summaries and action recommendations are explicitly scoped to regulatory context — pharmacovigilance, RA, and clinical — matching the working language of GxP teams.

EU-Hosted Infrastructure

NoxReg runs on Supabase (EU region) and Vercel edge nodes, ensuring your regulatory intelligence data never leaves European jurisdiction.

Full Audit Trail

Every regulatory update is timestamped and source-linked. The REST API enables your compliance team to pull structured records into Veeva Vault, SharePoint, or your QMS.

No Third-Party Data Sharing

Your agency filters, alert preferences, and watch terms are yours. We do not share subscriber configuration or behaviour data with any third party — ever.

GDPR CompliantEU InfrastructureTLS 1.3 EncryptedGxP-AwareNo Data SellingAPI-First

Testimonials

What regulatory professionals say.

Trusted by PV teams, RA directors, and CROs across Europe and North America

We used to spend 2 hours every morning checking agency websites. NoxReg reduced that to 10 minutes and we have not missed a critical update since.

DS

Dr. Sarah M.

Head of Pharmacovigilance · Mid-size European biotech

The AI summaries are genuinely useful. Not generic — they actually explain what an MHRA update means for a company with products on the UK market.

JK

James K.

Regulatory Affairs Director · Specialty pharma, London

As a consultant managing 8 client accounts, NoxReg's filter profiles let me set up a separate view per client. It is now an essential part of my workflow.

AL

Anaïs L.

Independent RA Consultant · Paris-based consultancy

The action recommendations for our PV team have cut our triage time dramatically. Knowing exactly who needs to act on what update — before anyone even reads it — is a game changer.

DM

Dr. Mikael B.

QPPV · Nordic specialty pharma

Pricing

Simple, transparent pricing.

Both plans include a 14-day free trial. No credit card required. Cancel anytime.

Starter
€199/month

~€2,388/year · cancel anytime

For individuals and small teams getting started with regulatory monitoring.

  • All 55+ agencies
  • AI summaries per article
  • Importance scoring
  • Category & agency filters
  • 2 saved filter profiles
  • CSV & PDF export
  • Weekly email digest
  • 90-day history
  • Daily email digest
  • Team action recommendations
  • REST API access
  • Unlimited filter profiles
Start free trial
⭐ Most popular
Pro
€699/month

~€6,990/year · 2 months free on annual

For regulatory teams that need full coverage, AI actions, and API access.

  • All 55+ agencies
  • AI summaries per article
  • Importance scoring
  • Category & agency filters
  • Unlimited filter profiles
  • CSV & PDF export
  • Daily + weekly email digest
  • Unlimited history
  • Team action recommendations
  • REST API access
  • 14-day free trial included
  • Priority email support

Need a custom team plan or annual contract? Contact us →

FAQ

Common questions.

NoxReg

Stop monitoring 55 websites manually.

Every day without NoxReg is a day you might miss a product recall, a submission deadline, or a guideline update your team needed to act on.

No credit card14-day free trialCancel anytimeGDPR compliant