Solutions by Industry
Built for Your Industry
Every life sciences organization has unique compliance needs. tfives provides
industry-specific solutions that address your specific challenges and scale as you grow.
Biotech Companies
Compliance in a Box. We Understand Your Pain
Because We've Been Like You.
You're building breakthrough therapies with limited
resources. Every dollar counts. Every day matters. You can't
afford a 20-person compliance team, but you can't afford
compliance failures either. We've been there. That's why we
built compliance in a box—everything you need, nothing
you don't. Deploy in days, not months. Scale as you grow.
Your Compliance in a Box:
✓ Core Bundle: AI governance, regulatory intelligence,
data integrity, privacy—everything essential, nothing extra
✓ ComplianceIQ: 48-hour AI readiness assessments
(not 6-month consulting engagements)
✓ AskRexi: Free regulatory chatbot—19 jurisdictions, 600+
rules (10 queries/day free)
✓ Clinical Bundle: Add when you're ready for trials—switch
on, not rebuild
Pharmaceutical Companies
Complete Compliance Coverage. One Platform.
Every Stage.
You manage complex product lifecycles across discovery,
development, manufacturing, and commercialization.
Multiple systems create compliance gaps. Regulatory
changes impact every division. tfives unifies your entire
compliance infrastructure—from AI governance to
commercial operations—on one integrated platform. Switch
on what you need, when you need it.
Your Complete Compliance Platform:
✓ Core Bundle: AI governance, regulatory intelligence, data
integrity, privacy—foundation for everything.
✓ Commercial OS: 8 integrated use cases—HCP engagement,
revenue optimization, promotional compliance.
✓ Manufacturing Bundle: GMP compliance, CAPA
management, quality systems, batch records.
✓ Clinical Bundle: Trial management, data systems,
pharmacovigilance, real-world data.
Perfect for: Top 10 global pharma, mid-market pharma, and specialty pharmaceutical companies managing full product lifecycles
Medical Device Manufacturers
FDA 510(k) and PMA submissions require thorough
validation. Manual IQ/OQ/PQ processes take months. One
compliance gap delays your entire product launch. RegIQ is
designed to validate itself for FDA submission—automatic
validation linkage, near-zero-downtime compliance, and
high submission success rate. Deploy with confidence.
Your FDA-Ready Platform:
✓ RegIQ: Self-validating platform for FDA submission—
automatic IQ/OQ/PQ, high success rate.
✓ Core Bundle: Data integrity, privacy, regulatory
intelligence—foundation for device compliance.
✓ Manufacturing Bundle: GMP compliance, quality
systems, batch records, supply chain.
✓ AskRexi: Real-time FDA 21 CFR Part 820 compliance
validation—free chatbot.
Contract Research
Organizations (CROs)
You manage multiple sponsor studies, each with different
compliance requirements. Data integrity across trials is
critical. GCP compliance can't fail. Sponsor audits require
perfect audit trails. tfives provides unified clinical trial
management, data integrity, and regulatory compliance—
ensuring GCP compliance across all trials while maintaining
sponsor-specific requirements.
Your Multi-Sponsor Platform:
✓ Clinical Bundle: Trial management, data systems,
pharmacovigilance—unified across all sponsors.
✓ Core Bundle: Data integrity, privacy, multi-jurisdictional
compliance—foundation for all trials.
✓ ClinoxisCore: Data integrity and audit trail management—
sponsor-ready audit trails.
✓ DataGovernanceIQ: AI-ready data governance and
privacy—protect sensitive trial data.
Perfect for: CROs managing multiple clinical trials with varying sponsor compliance requirements and audit needs
CDMOs
You manufacture for multiple clients, each with different
product requirements. GMP compliance can't fail—one
deviation impacts multiple clients. Batch records must be
perfect. Client audits require instant access to complete
audit trails. tfives ensures GMP compliance across all client
products with automated quality systems, self-validating
platforms, and client-ready batch records.
Your Multi-Client Manufacturing Platform:
✓ Manufacturing Bundle: GMP compliance, CAPA
management, quality systems—unified across all clients.
✓ RegIQ: Self-validating platform for FDA submission—
automatic validation, zero downtime.
✓ Core Bundle: Data integrity, privacy, regulatory intelligence—
foundation for manufacturing.
✓ ClinoxisCore: Batch record management and audit trails—
client-ready documentation.
Med Tech Companies
You're building the future of healthcare—combining
software, medical devices, and digital health solutions. But
compliance is complex: FDA device regulations, EU MDR,
software compliance, HIPAA, GDPR, and AI governance.
Each requires different expertise. tfives provides integrated
compliance across all your technologies—navigate FDA, EU
MDR, and software compliance on one unified platform.
Your Integrated Med Tech Platform:
✓ Core Bundle: AI governance, data privacy, regulatory
intelligence—foundation for all technologies.
✓ ComplianceIQ: AI/ML readiness for digital health solutions—
48-hour assessments.
✓ RegIQ: FDA submission and quality management—device
and software compliance.
✓ DataGovernanceIQ: HIPAA, GDPR compliance for patient
data—privacy-first architecture.
Perfect for: Med tech companies combining software, medical devices, and digital health solutions requiring multi-regulatory compliance
TFives solutions are modular. Start with the Core Bundle for essential compliance, then add Commercial OS,
Manufacturing, Clinical, or Medical Affairs bundles as your organization grows.
1
Start: Core Bundle
2
Grow: Add Clinical or Manufacturing
3
Scale: Add Commercial OS