Know what regulators
will say before they say it.
Gulfstream Intelligence is the AI platform that helps life sciences teams anticipate regulatory expectations, close gaps, and accelerate global approvals with confidence.
Anticipate Risk
Before Submission
Align Globally
Across Authorities
Accelerate Approvals
With Confidence
Full access to every feature for 7 days — no credit card required.
Your data is never used to train AI models.
Welcome back, Alex
Your Program at a Glance
Readiness Score
Moderate Risk
Top Risks
7
High Priority
View All
Top Gaps
14
Need Attention
View All
Simulation Insights
11
Likely Objections
View All
Continue where you left off
FDA Simulation
10m ago
CMC Gap Assessment
1h ago
IND Application Draft
Yesterday
Toxicology Report
2d ago
FIVE INTELLIGENCE ENGINES. ONE REGULATORY ADVANTAGE.
Regulatory Chat
Get defensible regulatory answers in seconds.
- Program-specific intelligence
- Global authority perspectives
- Citations from guidance & precedent
- Persistent memory across chats
Global Gap Assessment
Know exactly what will get flagged before submission.
- FDA, EMA, PMDA & more
- Domain-based scoring engine
- Severity, impact & sequencing
- Actionable recommendations
Health Authority Simulation
Anticipate FDA / EMA objections before they happen.
- AI models of reviewer behavior
- Likely questions & objections
- Authority-specific feedback
- Strengthen your response strategy
Document Intelligence
Turn thousands of pages into clear regulatory strategy.
- Extract key insights in seconds
- Gap & risk identification
- Inconsistency detection
- Regulatory implications mapped
Regulatory Intelligence & Policy
Stay ahead of regulatory change, policy, legislation, and agency activity.
- Guidance & legislative updates
- Agency meetings & events
- AI summaries & impact analysis
- Connected to your projects
YOUR REGULATORY CORE
One source of truth for your entire program.
The Regulatory Core centralizes all intelligence across documents, strategy, risks, and decisions—so your team stays aligned and always ready.
Centralized Intelligence
All documents, strategies, gaps, risks, and decisions in one living knowledge base.
Connected Across Modules
Chat, gaps, simulations, and documents work together—always aligned.
Core Intelligence
Continuously learns from new data, signals, and decisions to improve outcomes.
Persistent Memory
Remembers your program context across sessions, so you never start over.
Smarter Over Time
Every insight improves your readiness score and strategic decisions.
BUILT FOR CONFIDENTIALITY. ENGINEERED FOR TRUST.
Your data is never used to train AI models.
Private, isolated environments available.
Built for confidential submissions & dossiers.
Enterprise-grade security (SOC 2 Type II roadmap).
AES-256 encryption in transit & at rest.
Hosted on GCP with 99.9% uptime.
FLEXIBLE PLANS. DESIGNED FOR REGULATORY TEAMS.
Full access to every feature for 7 days — no credit card required.
Individual
For independent regulatory professionals and consultants.
Billed monthly
Includes 1 month free
with annual billing
Includes:
- Regulatory Chat
- Powered by OpenAI & Claude models
- General + Program Mode
- Document Intelligence
- Global Gap Assessment
- Health Authority Simulation
- Project Workspace
- Standard exports
Business
For biotech teams and collaborative regulatory organizations.
Up to 5 users included
Includes 1 month free
with annual billing
Includes everything in Individual, plus:
- Shared projects & folders
- Shared Regulatory Core
- Team collaboration tools
- Advanced simulations
- Centralized document management
- Admin controls
Enterprise
Custom infrastructure for global regulatory organizations.
Custom Pricing
Tailored to your organization's needs.
Includes everything in Business, plus:
- Unlimited users
- Dedicated onboarding
Powered by OpenAI & Claude
Access leading AI models for regulatory intelligence.
Global Regulatory Coverage
Stay informed across major health authorities worldwide.
Secure & Compliant
Enterprise-grade security with privacy and data protection.
Built for Life Sciences
Purpose-built for regulatory professionals and teams.
All plans include secure data handling, multi-model AI access, and global regulatory coverage.
Built to support qualified regulatory professionals, not replace them.
Program Mode provides controlled-source intelligence using approved documents and designated regulatory resources, while General Mode enables broader AI-assisted research, drafting, and analysis. All outputs should be independently reviewed and approved by qualified personnel prior to use in regulated activities.
Built by Regulatory Experts.
Backed by Real-World Experience.
Decades of global regulatory leadership across FDA, EMA, MHRA, Health Canada, PMDA, TGA, and NMPA—now powered by AI to help you move your program forward.
25+
Years Regulatory
Leadership
Global
Experience Across
Major Health Authorities
1000+
Submissions
Supported
Trusted
By Biotech, Pharma &
Medtech Device Leaders
Global Perspective.
Local Expertise.
Navigate regulatory pathways with confidence across every major health authority worldwide.
FDA
USA
EMA
EU
MHRA
UK
Health Canada
Canada
PMDA
Japan
TGA
Australia
& More
Know what regulators will say before they say it.
Join life sciences leaders using Gulfstream Intelligence to make smarter regulatory decisions—faster.
Enterprise & Sales
Ready for enterprise-grade regulatory intelligence?
Get a personalized demo, custom pricing, and dedicated support for your organization. Our team typically responds within one business day.
Custom integrations
Connect with your existing regulatory systems and workflows.
Dedicated support
A named account manager and priority SLA.
Compliance-ready
Data handling agreements, audit trails, and SSO on request.