About tfives

Transforming Pharmaceutical Compliance from a Bottleneck into a Competitive Advantage

We're on a mission to eliminate regulatory friction so pharmaceutical innovation reaches patients faster. Compliance shouldn't slow down life-saving therapies—it should accelerate them.

The tfives Foundation: The 5 Ts

Together, Transforming with Trust, Transparency, and Technology

These five principles guide every solution we build and every partnership we form, ensuring compliance excellence across the complete pharmaceutical product lifecycle.

01

Together

Discovery

Collaborative innovation from the start

We partner with you from day one, ensuring compliance is built into your innovation process, not bolted on afterward.

02

Transforming

Development

Continuous evolution and improvement

We don't just solve today's problems—we build systems that evolve with regulations, technology, and your business needs.

03

Trust

Manufacturing

Reliable, validated processes

Every system is validated, every process is auditable, and every decision is traceable. Trust is built into our DNA.

04

Transparency

Launch

Clear visibility and accountability

Complete visibility into compliance status, risks, and opportunities. No black boxes, no surprises—just clarity.

05

Technology

Post-Market

Innovation-driven solutions

Cutting-edge AI, automation, and intelligence that makes compliance faster, smarter, and more effective.

Our Mission

Eliminate regulatory friction so pharmaceutical innovation reaches patients faster.

We believe compliance shouldn't slow down life-saving therapies—it should accelerate them. Every day of delay means patients waiting for treatments, competitors gaining advantage, and opportunities lost.

Our Vision

A world where pharmaceutical compliance is invisible, intelligent, and instantaneous.

We envision a future where compliance is built into every pharmaceutical innovation from day one—where regulatory excellence is a competitive advantage, not a cost center.

What We Do

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 (8 integrated use cases), and clinical operations into one unified system.

Unlike point solutions that create silos, tfives ensures compliance continuity across all stages of pharmaceutical development and commercialization. We're not just another vendor—we're your compliance infrastructure partner. Learn more about our industry-specific solutions and use case implementations.

Our Platform Includes:

ComplianceIQ

AI/ML readiness & governance

AskRexi

Conversational compliance chatbot

ClinoxisCore

Compliance marketplace & APIs

DataGovernanceIQ

AI-ready data governance

RegIQ

Regulatory & quality suite

CommercialCore

8 integrated commercial use cases

Why tfives Exists

Our Team's Experience

Pharmaceutical Compliance

Deep expertise in GxP validation, FDA 21 CFR Part 11, and regulatory affairs across the complete product lifecycle.

FDA & Regulatory

Former FDA reviewers and regulatory affairs experts with direct experience in submissions, inspections, and compliance.

Technology Companies

Built enterprise AI systems and compliance infrastructure at IBM, IQVIA, and leading technology organizations.

Leading Consulting

Strategic advisors from IBM, ZS, Wipro, Infosys, Deloitte and other top consulting firms, specializing in digital transformation and pharmaceutical technology.

We understood what others overlooked: Pharmaceutical compliance is the bottleneck preventing life-saving drugs from reaching patients.

After decades of collective experience working deep in pharmaceutical compliance, FDA regulatory affairs, technology companies, and leading consulting firms, we kept seeing the same pattern:

Brilliant pharmaceutical teams with breakthrough therapies—stuck in extended compliance validation cycles.

Every month of delay meant:

  • Patients not receiving treatment
  • Competitors filing first
  • Significant opportunity costs
  • R&D investment at risk

These delays weren't scientific problems. They were infrastructure problems.

That's why we founded tfives—to transform pharmaceutical compliance from a cost center into a competitive advantage.

Our Approach

Three principles that guide everything we build

Speed

48-hour AI compliance assessments vs. months of manual validation

We've reduced compliance assessment time from typically 1 months totypically typically within Typically within 48 hours. Deploy in days, not months. Scale instantly.

Integration

One platform connecting all compliance functions—no silos

All systems communicate natively. Near-zero API chasm. Near-zero integration costs. Switch on what you need, when you need it.

Intelligence

AI-powered compliance that predicts risks before they become problems

Proactive risk detection, automated validation, and predictive analytics. Compliance that gets smarter over time.

Our Track Record

Proven results across the pharmaceutical industry

Multiple
Life Sciences Companies

From startup to enterprise

Industry-Leading
FDA Inspection Pass Rate

Across our customers

All Systems
In Production

Live in production today

20+
Years Experience

In pharmaceutical technology

Who We Serve

Emerging biotech companies (Pre-IND through Phase 3)
Top 10 global pharmaceutical companies
Leading contract research organizations
Medical device manufacturers
Specialty pharmaceutical companies
CDMOs and manufacturing organizations

Built on Expertise, Authority, and Trust

Our team brings decades of pharmaceutical technology experience from leading organizations

Certifications & Compliance

🔒

SOC 2 Type II

Security & Compliance

ISO 27001

Information Security

🏥

FDA 21 CFR Part 11

Electronic Records

⚙️

GAMP 5

Pharmaceutical Validation

Proven Results

Early-Stage Biotech Achieves First-Time Approval

Pre-submission AI compliance assessment identified critical risks. All resolved before regulatory review, resulting in record time to approval and zero 483 observations.

✓ First-time approval ✓ Strong compliance track record
Read Full Case Study →

Enterprise Pharma Unifies Compliance Platform

Replaced multiple disconnected systems with unified tfives platform. Real-time visibility across multiple manufacturing sites in global jurisdictions, achieving industry-leading inspection pass rates and significant reduction in compliance costs.

✓ Industry-leading pass rate ✓ Significant cost reduction
Read Full Case Study →

Industry Recognition

Industry-Leading
FDA Inspection Pass Rate

Across all active customers

Strong
Data Integrity Track Record

For active customers

High
Customer Satisfaction

Based on implementation success

Ready to Transform Your Compliance?

Join multiple life sciences companies who trust tfives to accelerate their innovation.