Compliance in a Box. Built for Every Life Sciences Organization.
We understand your pain because we've been there. That's why we built compliance in a box—everything you need, nothing you don't. From emerging biotech to global pharma, from CROs to medical device manufacturers—tfives provides industry-specific compliance solutions that scale with your organization. Deploy in days, not months. Switch on what you need, when you need it.
Every life sciences organization has unique compliance needs. tfives provides industry-specific solutions that address your specific challenges and scale as you grow.
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.
"We built tfives because we know what it's like to be a biotech founder—racing against time, managing burn rate, and needing enterprise-grade compliance without enterprise-sized teams."
Perfect for: Pre-IND through Phase 3 biotech companies who need enterprise compliance without enterprise complexity
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.
Perfect for: Top 10 global pharma, mid-market pharma, and specialty pharmaceutical companies managing full product lifecycles
FDA Submission Confidence. Self-Validating Platform. Near-Zero Downtime.
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.
Perfect for: Medical device companies requiring FDA 510(k), PMA, and quality management system compliance
Multi-Sponsor Compliance. One Platform. Near-Zero Integration Headaches.
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.
Perfect for: CROs managing multiple clinical trials with varying sponsor compliance requirements and audit needs
Multi-Client GMP Compliance. Perfect Batch Records. Client-Ready Audits.
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.
Perfect for: CDMOs requiring GMP compliance and quality management across multiple client products and manufacturing lines
Software + Device + Digital Health. One Compliance Platform. All Regulations.
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.
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.
Start: Core Bundle
AI governance, regulatory intelligence, data integrity, privacy—the foundation every organization needs
Grow: Add Clinical or Manufacturing
Add Clinical Bundle for trial management or Manufacturing Bundle for GMP compliance
Scale: Add Commercial OS
Add Commercial OS with 8 integrated use cases when you're ready to commercialize