Program Mode
Ground answers in approved program documents and designated regulatory sources.
- Controlled-source intelligence
- Citations and program memory
OpenAI GPT-5.6Regulatory grounding
Learn more AI REGULATORY INTELLIGENCE SOFTWARE FOR LIFE SCIENCESAI regulatory intelligence
AI regulatory intelligence
for pharma and biotech—
connected to execution.
Gulfstream Intelligence connects research, program evidence, gap assessment, authority preparation, submission planning, and decision-ready deliverables in one regulatory workflow.
Anticipate Risk
Before Submission
Align Globally
Across Authorities
Accelerate Approvals
With Confidence
Choose a Plan — Card Required
$0 today. Your selected plan starts after the 7-day trial and renews automatically until canceled. Cancel before the trial ends to avoid the first charge.
Your data is never used to train AI models.
Welcome back
Your Program: AAV Gene Therapy for DMDPhase 1INDGlobal
Ask anything about your program, strategy, or regulatory requirements...
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
From intelligence to execution
Powerful AI. One connected regulatory workflow.
Start with program-grounded intelligence, move through planning and monitoring, and finish with decision-ready deliverables—without losing context between tools.
Submission Planner
Build complete submission plans for INDs, NDAs, BLAs, MAAs, and more.
- CTD structure and workflows
- Milestones, dates and dependencies
Regulatory Intelligence & Policy
Monitor regulatory change and connect relevant impacts to active projects.
- Guidance, policy and events
- Impact analysis and executive briefs
Slide Studio
Turn regulatory work into evidence-grounded, branded, editable PowerPoints.
- Chats, documents, plans and meetings
- Editable slides with source links
Eleven core capabilities. One regulatory advantage.
Regulatory Chat
Get defensible regulatory answers in seconds.
- General and Program Mode
- Global authority perspectives
- Citations from guidance and precedent
- Persistent memory across chats
Global Gap Assessment
Know what will get flagged before submission.
- FDA, EMA, PMDA and more
- Readiness and severity scoring
- Impact and sequencing analysis
- Prioritized recommendations
Health Authority Simulation
Pressure-test your strategy before the meeting.
- Likely questions and objections
- Authority-specific perspectives
- Realistic reviewer behavior
- Response strategy development
Document Intelligence
Turn source documents into clear regulatory strategy.
- Rapid insight extraction
- Gap and risk identification
- Inconsistency detection
- Regulatory implications mapped
Regulatory Intelligence & Policy
Turn regulatory change into project-level action.
- Guidance, policy and agency activity
- Project-specific impact analysis
- Regulatory events and watchlists
- Executive briefs and next steps
Submission Planner
Build the complete submission flow before work begins.
- IND, NDA, BLA and MAA structures
- CTD structure and complete workflows
- Milestones and dependencies
- Target dates and assumptions
Slide Studio
Turn regulatory work into decision-ready presentations.
- Evidence-grounded narratives
- Editable branded PowerPoints
- Chats, documents, plans and meetings
- Source links carried forward
Meeting Intelligence
Convert every meeting into accountable follow-through.
- Recaps and structured minutes
- Decision and action extraction
- Calendar and file organization
- Owners, dates and shared outputs
Writing Assistant
Create clearer communications without changing intent.
- Email, Teams and long-form formats
- Audience and objective controls
- Editable polished drafts
- Plain-language revisions
Document Translator
Translate regulatory documents while preserving critical terms.
- Automatic language detection
- Identifiers and agency names preserved
- PDF, DOCX, PPTX, TXT and images
- DOCX and PDF export
Project Workspaces
Keep every program, team, and output connected.
- Shared program context
- Connected analyses and deliverables
- Program and authority organization
- Organized team collaboration
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, planning, intelligence, simulations, documents, and deliverables stay 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 and operated in-house—no outside contractors work on Gulfstream code or infrastructure.
Designed for confidential regulatory submissions and dossiers.
Encryption in transit and at rest.
FLEXIBLE PLANS. DESIGNED FOR REGULATORY TEAMS.
Introductory pricing for new customers
MonthlyAnnualSave up to $300 per year
Choose a plan below to start your free 7-day trial
Card required. $0 today. Paid billing starts after the 7-day trial and renews automatically until canceled.
Individual
For independent regulatory professionals and consultants.
$649USD / year
Billed once annually · about $54.08/month
Save $59 compared with monthly billing
Includes:
- Regulatory Chat
- Advanced AI for regulatory work
- General + Program Mode
- Document Intelligence
- Global Gap Assessment
- Health Authority Simulation
- Project Workspace
- Standard exports
$0 today. $649/year starting after the 7-day trial, then automatically renews annually until canceled. Cancel before the trial ends to avoid the first charge.
Most PopularStart 7-day trial — card required
Business
For biotech teams and collaborative regulatory organizations.
$3,000USD / year
Billed once annually · about $250.00/month
Save $300 compared with monthly billing
Includes up to 5 users
Includes everything in Individual, plus:
- Shared projects & folders
- Shared Regulatory Core
- Team collaboration tools
- Advanced simulations
- Centralized document management
- Admin controls
$0 today. $3,000/year starting after the 7-day trial, then automatically renews annually until canceled. Cancel before the trial ends to avoid the first charge.
Enterprise
Custom infrastructure for global regulatory organizations.
Custom Pricing
Tailored to your organization's needs.
Includes everything in Business, plus:
- Unlimited users
- Dedicated onboarding
Enterprise AI, Regulatory Focus
Use advanced AI built into a controlled regulatory workflow.
Global Regulatory Coverage
Stay informed across major health authorities worldwide.
Security & Privacy
Secure data handling and documented privacy practices.
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.
7-day free trial · Full feature access · Card required
$0 is due today. After Stripe Checkout, your selected monthly or annual subscription starts charging automatically when the 7-day trial ends and then renews until canceled. Prices are in USD; applicable taxes may be added. Cancel during the trial to avoid the first charge.
Business includes up to 5 users. Contact us for additional seats or enterprise terms.
Keep your introductory subscription price while the same subscription remains continuously active. Plan or billing changes and later resubscriptions may use the price then available.
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.