Significant
Average Cost reduction
Real time
Instant regulatory alerts (global jurisdictions)
Unified
One compliance operating system
Co-creating the Compliance
Infrastructure for Life Sciences Innovation
Co-creating the
Compliance Infrastructure for Life Sciences Innovation
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.
Join multiple life sciences companies that use TFives to assess, automate, and activate their compliance—and accelerate life-saving therapies to patients.
Trusted by pharmaceutical companies from emerging biotech to top 10 global pharma
Leading Biotech
Leading Biotech Enterprise Pharma Global CRO + startup companies
Enterprise Pharma
Leading Biotech Enterprise Pharma Global CRO + startup companies
Global CRO
New Age Pharma
Leading Biotech Enterprise Pharma Global CRO + startup companies
Why Traditional Compliance
Fails Pharmaceutical Companies
Why Traditional Compliance Fails Pharmaceutical Companies
Months for AI
Compliance Validation
Manual AI/ML compliance assessments take quarters
while competitors submit AI-powered applications FDA
guidance evolves daily—most models aren't compliant.
40% of AI submissions face delays or rejections
Months for AI
Compliance Validation
Manual AI/ML compliance assessments take quarters
while competitors submit AI-powered applications FDA
guidance evolves daily—most models aren't compliant.
40% of AI submissions face delays or rejections
Months for AI
Compliance Validation
Manual AI/ML compliance assessments take quarters
while competitors submit AI-powered applications FDA
guidance evolves daily—most models aren't compliant.
40% of AI submissions face delays or rejections
Tracking Global Regulations
Manually Is Challenging
Different requirements across FDA, EMA, PMDA create
compliance gaps. Most pharma companies miss regulatory
updates across global markets.
Multiple jurisdictions, hundreds of regulations,
limited visibility
Tracking Global Regulations
Manually Is Challenging
Different requirements across FDA, EMA, PMDA create
compliance gaps. Most pharma companies miss regulatory
updates across global markets.
Multiple jurisdictions, hundreds of regulations,
limited visibility
Tracking Global Regulations
Manually Is Challenging
Different requirements across FDA, EMA, PMDA create
compliance gaps. Most pharma companies miss regulatory
updates across global markets.
Multiple jurisdictions, hundreds of regulations,
limited visibility
Disconnected Systems
Create FDA 483s
QMS doesn't communicate with regulatory systems. Data
governance doesn't integrate with AI validation. Critical
compliance requirements fall through the cracks.
40% of AI submissions face delays or rejections
Disconnected Systems
Create FDA 483s
QMS doesn't communicate with regulatory systems. Data
governance doesn't integrate with AI validation. Critical
compliance requirements fall through the cracks.
40% of AI submissions face delays or rejections
Disconnected Systems
Create FDA 483s
QMS doesn't communicate with regulatory systems. Data
governance doesn't integrate with AI validation. Critical
compliance requirements fall through the cracks.
40% of AI submissions face delays or rejections
How TFives Transforms
Pharmaceutical Compliance
The Before
❌ Reactive: Regulators find issues during audits
❌ Slow: Months for AI validation
❌ Blind: Miss regulatory changes
❌ Siloed: Systems don't communicate
❌ Scrambling: Weeks for inspection prep
❌ No AI Governance: High rejection rates
The Before
❌ Reactive: Regulators find issues during audits
❌ Slow: Months for AI validation
❌ Blind: Miss regulatory changes
❌ Siloed: Systems don't communicate
❌ Scrambling: Weeks for inspection prep
❌ No AI Governance: High rejection rates
The Before
❌ Reactive: Regulators find issues during audits
❌ Slow: Months for AI validation
❌ Blind: Miss regulatory changes
❌ Siloed: Systems don't communicate
❌ Scrambling: Weeks for inspection prep
❌ No AI Governance: High rejection rates
The After
✓ Predictive: Identify risks 90 days ahead
✓ Fast: 48-hour AI compliance assessment
✓ Real-time: Instant regulatory alerts (global jurisdictions)
✓ Unified: One compliance operating system
✓ Ready: Hours to generate audit reports
✓ Pre-Certified: Superior first-time approval rates
The After
✓ Predictive: Identify risks 90 days ahead
✓ Fast: 48-hour AI compliance assessment
✓ Real-time: Instant regulatory alerts (global jurisdictions)
✓ Unified: One compliance operating system
✓ Ready: Hours to generate audit reports
✓ Pre-Certified: Superior first-time approval rates
The After
✓ Predictive: Identify risks 90 days ahead
✓ Fast: 48-hour AI compliance assessment
✓ Real-time: Instant regulatory alerts (global jurisdictions)
✓ Unified: One compliance operating system
✓ Ready: Hours to generate audit reports
✓ Pre-Certified: Superior first-time approval rates
Six Pillars of Modern Pharmaceutical Compliance
Six Pillars of Modern
Pharmaceutical Compliance
One unified platform connecting AI compliance infrastructure, conversational regulatory intelligence,
compliance marketplace APIs, data governance, manufacturing quality, and commercial compliance.
One unified platform connecting AI compliance infrastructure, conversational
regulatory intelligence, compliance marketplace APIs, data governance,
manufacturing quality, and commercial compliance.
ComplianceIQ
Universal AI Compliance Infrastructure
Stop letting compliance freeze your AI projects. Minimal
technical debt. Deploy in days, not months.
Learn More →
ComplianceIQ
Universal AI Compliance Infrastructure
Stop letting compliance freeze your AI projects. Minimal
technical debt. Deploy in days, not months.
Learn More →
ComplianceIQ
Universal AI Compliance Infrastructure
Stop letting compliance freeze your AI projects. Minimal
technical debt. Deploy in days, not months.
Learn More →
AskRexi
Your Conversational AI Chatbot for Pharma Compliance
Stop letting compliance freeze your AI projects. Minimal
technical debt. Deploy in days, not months.
Learn More →
AskRexi
Your Conversational AI Chatbot for Pharma Compliance
Stop letting compliance freeze your AI projects. Minimal
technical debt. Deploy in days, not months.
Learn More →
AskRexi
Your Conversational AI Chatbot for Pharma Compliance
Stop letting compliance freeze your AI projects. Minimal
technical debt. Deploy in days, not months.
Learn More →
ClinoxisCore
The Pharmaceutical Compliance Marketplace
Transform months of consulting into minutes. 1,200+ APIs,
145+ use cases, 25+ compliance frameworks.
Learn More →
ClinoxisCore
The Pharmaceutical Compliance Marketplace
Transform months of consulting into minutes. 1,200+ APIs,
145+ use cases, 25+ compliance frameworks.
Learn More →
ClinoxisCore
The Pharmaceutical Compliance Marketplace
Transform months of consulting into minutes. 1,200+ APIs,
145+ use cases, 25+ compliance frameworks.
Learn More →
DataGovernanceIQ
The Pharmaceutical Compliance Marketplace
GDPR, HIPAA, CCPA pre-certified. Zero-trust
data governance architecture.
Learn More →
DataGovernanceIQ
The Pharmaceutical Compliance Marketplace
GDPR, HIPAA, CCPA pre-certified. Zero-trust
data governance architecture.
Learn More →
DataGovernanceIQ
The Pharmaceutical Compliance Marketplace
GDPR, HIPAA, CCPA pre-certified. Zero-trust
data governance architecture.
Learn More →
RegIQ
Automated pharma validation within CAPA workflows
AI-powered platform designed to validate itself for FDA
submission. Automatic IQ/OQ/PQ validation, eCTD generation.
Learn More →
RegIQ
Automated pharma validation within CAPA workflows
AI-powered platform designed to validate itself for FDA
submission. Automatic IQ/OQ/PQ validation, eCTD generation.
Learn More →
RegIQ
Automated pharma validation within CAPA workflows
AI-powered platform designed to validate itself for FDA
submission. Automatic IQ/OQ/PQ validation, eCTD generation.
Learn More →
CommercialCore
Automated pharma validation within CAPA workflows
One platform. 8 integrated use cases. Switch on what you
need. From HCP engagement to revenue optimization.
Learn More →
CommercialCore
Automated pharma validation within CAPA workflows
One platform. 8 integrated use cases. Switch on what you
need. From HCP engagement to revenue optimization.
Learn More →
CommercialCore
Automated pharma validation within CAPA workflows
One platform. 8 integrated use cases. Switch on what you
need. From HCP engagement to revenue optimization.
Learn More →
Everything Connects. Everything Compounds.
Everything Connects.
Everything Compounds.
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
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