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Automated Regulatory Intelligence & Surveillance

Continuous 24/7 monitoring of FDA, EMA, Health Canada, MHRA, and CDSCO updates. Deliver clear, verified document summaries filtered precisely to your therapeutic areas.

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12+ Global Agencies
Therapeutic Filtering
Instant Telegram Alerts
RegulatoryAlerts Intelligence Hub
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Active Filters:FDA CDEROncologyEMA
Updated 12 mins ago
FDA CDERGuidance for Industry
High Impact

Adaptive Clinical Trial Designs for Drugs & Biologics

Executive Summary:Updated FDA guidance establishes revised thresholds for Bayesian adaptive trial interim analyses, requiring documented data monitoring committee protocols prior to Phase II initiation.

EMACHMP Positive Opinion
New Approval

Expanded Approval Granted for Targeted Immunotherapy

Executive Summary:EMA CHMP recommended approval for second-line treatment of relapsed mantle cell lymphoma following Phase III progression-free survival metrics.

Global Surveillance Reach

12+ Regulatory Agencies Monitored Around the Clock

FDA
US FDA (CDER, CBER, CDRH)
United States
EMA
European Medicines Agency
European Union
HC
Health Canada (HPFB)
Canada
MHRA
MHRA Regulatory Agency
United Kingdom
CDSCO
Central Drugs Standard Control
India
TGA
Therapeutic Goods Admin
Australia
WHO
World Health Organization
Global Pre-qualifications
SWISS
Swissmedic
Switzerland
Platform Capabilities

Designed for High-Consequence Regulatory Surveillance

Eliminate manual portal checks and subscription fatigue. Get structured, actionable intelligence directly delivered.

Always-On Surveillance
Automated scraping engines check FDA, EMA, Health Canada, and MHRA portals multiple times per hour. Receive notifications long before updates hit public news outlets.
Precision Therapeutic Filtering
Filter out irrelevant noise. Focus strictly on Oncology, Cardiology, Rare Diseases, Vaccines, Gene Therapy, or specific document types like draft guidances and warning letters.
Executive Document Summaries
Skip reading 60-page PDF guidance documents. Our structured analysis extracts key regulatory implications, effective timelines, and recommended protocol actions in seconds.

Tailored for Key Life Science Functions

Whether you manage global submissions, clinical protocols, or manufacturing quality.

RA

Regulatory Affairs

Track precedent approvals, guidance updates, and advisory committee schedules to maintain compliant submission strategies and reduce approval cycles.

CO

Clinical Operations

Stay updated on IND safety reporting mandates, clinical trial endpoint guidance, and protocol amendments across target trial jurisdictions.

QA

Quality Assurance & Compliance

Monitor GMP revisions, FDA warning letter trends, and CMC regulatory updates to ensure facility readiness and prevent audit findings.

MA

Medical & Commercial Strategy

Track label expansions, black box warnings, and competitor drug approvals to inform portfolio planning and market entry timelines.

Why RegulatoryAlerts vs. Legacy RIM Software?

❌ Legacy RIM (Veeva, Kivo, etc.)

  • ✗$10,000 – $50,000 per year
  • ✗6-month implementation time
  • ✗Complex, bloated interface
  • ✗Requires extensive training
  • ✗Locked into annual contracts
  • ✗No intelligent document summaries
  • ✗Manual setup for each agency

✅ RegulatoryAlerts

  • ✓Starting at just $39.99/month (cancel anytime)
  • ✓2-minute setup — instant value from day one
  • ✓Beautiful, modern interface
  • ✓Intuitive — anyone can use it immediately
  • ✓Cancel anytime — flexible month-to-month
  • ✓Intelligent document summaries
  • ✓12+ agencies pre-configured, ready to go

Perfect for individuals, small teams, and companies that don't need enterprise bloatware

5+ Hours
Saved Per Specialist / Week
12+ Agencies
Monitored 24 Hours a Day
< 24 Hours
Digest Delivery Speed

Never Miss a Critical Regulatory Update Again

Join regulatory affairs professionals saving 5+ hours every week. Start your 14-day trial for just $1.

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Automated regulatory intelligence monitoring for pharmaceutical and biotech professionals. Track FDA, EMA, and Health Canada updates seamlessly.

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