tfives: AI innovation meets regulatory trust
Join multiple life sciences companies that use tfives to assess, automate, and activate their compliance—and accelerate life-saving therapies to patients.
✓ No credit card required ✓ 48-hour results ✓ Trusted by leading pharmaceutical companies
Trusted by pharmaceutical companies from emerging biotech to top 10 global pharma
Manual AI/ML compliance assessments take quarters while competitors submit AI-powered applications. FDA guidance evolves daily—most models aren't compliant.
Different requirements across FDA, EMA, PMDA create compliance gaps. Most pharma companies miss regulatory updates across global markets.
QMS doesn't communicate with regulatory systems. Data governance doesn't integrate with AI validation. Critical compliance requirements fall through the cracks.
One unified platform connecting AI compliance infrastructure, conversational regulatory intelligence, compliance marketplace APIs, data governance, manufacturing quality, and commercial compliance.
Universal AI Compliance Infrastructure
Stop letting compliance freeze your AI projects. Minimal technical debt. Deploy in days, not months.
Your Conversational AI Chatbot for Pharma Compliance
Chat naturally with REXI about regulatory compliance. Free at AskREXI.com — 10 queries per day.
The Pharmaceutical Compliance Marketplace
Transform months of consulting into minutes. 1,200+ APIs, 145+ use cases, 25+ compliance frameworks.
GDPR, HIPAA, CCPA pre-certified. Zero-trust data governance architecture.
AI-powered platform designed to validate itself for FDA submission. Automatic IQ/OQ/PQ validation, eCTD generation.
One platform. 8 integrated use cases. Switch on what you need. From HCP engagement to revenue optimization.
When ComplianceIQ detects AI risk → AskRexi (chatbot) auto-checks regulations → ClinoxisCore validates data → RegIQ generates investigation → DataGovernanceIQ ensures privacy → CommercialCore manages commercial operations with 8 integrated use cases
Integrated compliance solutions supporting the complete pharmaceutical product lifecycle—from discovery through lifecycle management.
Build Compliance into Innovation
Accelerate Clinical Development
First-Time Global Approval
Commercialize at Scale
Maximize Lifecycle Value
Challenge: Preclinical data isn't GxP-compliant, AI models lack regulatory documentation
Challenge: Protocol deviations, data integrity issues, safety signals missed
Challenge: Multi-jurisdictional conflicts, AI documentation gaps, manufacturing readiness issues
Challenge: HCP compliance tracking, promotional violations, manufacturing scale-up gaps
Challenge: Continuous safety monitoring, label expansions, ongoing GMP, generic competition
tfives is the only platform that provides integrated compliance from discovery through lifecycle. When you validate AI models in discovery (ComplianceIQ), that documentation carries through clinical development, regulatory approval, commercial launch, and lifecycle management—eliminating redundant work and ensuring consistency.
Tailored solutions for every role in pharmaceutical compliance—from executives to engineers
Complete visibility into enterprise compliance health
Visual workflows with drag-and-drop simplicity
Integrate compliance into your workflow
from complianceiq import SDK
result = SDK.check_model(...)Transforming pharmaceutical compliance from a bottleneck into a competitive advantage
tfives is building the Compliance Intelligence Platform for Pharmaceutical Innovation. We provide integrated compliance solutions that span the complete product lifecycle—from discovery through lifecycle management. Our platform connects AI validation, regulatory intelligence, data integrity, manufacturing quality, commercial operations, and clinical operations into one unified system.
Founded by industry veterans with 20+ years at IBM, IQVIA, and leading consulting firms, we've seen firsthand how compliance delays prevent life-saving therapies from reaching patients. That's why we built tfives—to eliminate regulatory friction and accelerate pharmaceutical innovation.
How Early-Stage Biotech Achieved First-Time Approval
Pre-submission AI compliance assessment identified critical risks. All resolved before regulatory review.
Enterprise Pharma Unifies Compliance Platform
Replaced multiple disconnected systems with unified tfives platform. Real-time visibility across multiple manufacturing sites in global jurisdictions.
Evidence Generation Accelerated Dramatically
MediusIQ accelerated real-world evidence studies from months to weeks. Quantified Medical Affairs ROI.
Most platforms offer compliance in pieces. tfives offers complete compliance infrastructure—integrated and working together.
When ComplianceIQ detects AI model bias → AskRexi automatically validates against current FDA AI/ML guidance
When ClinoxisCore flags data integrity gap → RegIQ generates investigation with complete audit trail
When AskRexi detects FDA guidance update → All affected systems receive instant alerts and validation checks
When RegIQ identifies deviation → AskRexi checks if reportable event and drafts regulatory notification
"tfives isn't six compliance tools. It's one compliance operating system."
Everything you need to know about pharmaceutical compliance with tfives
tfives is an integrated compliance operating system designed for pharmaceutical and life sciences companies. It covers AI governance, manufacturing quality (GxP), commercial operations, and regulatory intelligence in a single unified platform. Unlike point solutions, tfives eliminates technical debt by providing end-to-end compliance coverage from drug discovery through commercial launch.
Our free AI compliance assessment delivers comprehensive results typically within 48 hours. The assessment identifies compliance gaps, evaluates risk levels, and provides actionable recommendations aligned with FDA 21 CFR Part 11, GAMP 5, and other relevant regulatory frameworks. No credit card or lengthy procurement process required.
Yes, tfives is built for FDA and GxP compliance from the ground up. The platform maintains SOC 2 Type II certification, ISO 27001 compliance, and adheres to FDA 21 CFR Part 11 and GAMP 5 standards. Our customers have achieved industry-leading FDA inspection pass rates, with all systems successfully validated and running in production environments.
tfives serves the full spectrum of life sciences organizations, including emerging biotech companies (Pre-IND through Phase 3), top 10 global pharmaceutical companies, contract research organizations (CROs), medical device manufacturers, and specialty pharmaceutical companies. Our platform scales from startup to enterprise needs.
tfives is the only integrated compliance operating system that covers the entire pharmaceutical value chain. Unlike fragmented point solutions, we provide unified AI governance, quality management, regulatory intelligence, and commercial compliance in one platform. This eliminates integration complexity, reduces technical debt, and accelerates time-to-market while maintaining full regulatory compliance.
Pricing is customized based on your organization's size, use cases, and compliance requirements. We offer flexible deployment options including SaaS, private cloud, and on-premise installations. Start with our free 48-hour AI compliance assessment to understand your specific needs, then our team will provide a tailored proposal. Contact our sales team for detailed pricing information.
Still have questions?
Talk to Our Compliance Experts →See how tfives helps pharmaceutical companies from startup to enterprise automate compliance, accelerate submissions, and eliminate regulatory risk.
Professional-Grade Assessment • No Credit Card Required
For teams that want:
Multiple life sciences companies | Industry-leading FDA inspection pass rate | All systems in production
Expert guidance on pharmaceutical compliance and AI governance
Whitepaper
Essential framework for implementing AI governance that meets FDA expectations and accelerates innovation.
Download Free Guide →Case Study
Real-world implementation of integrated compliance platform reducing validation time by 70%.
Read Case Study →Webinar
Expert panel discussion on emerging regulatory requirements and compliance strategies.
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