RegulatoryFlow transforms regulatory documentation with AI-powered Text Engineering, virtually eliminating errors from both human work and generative AI
Limited-Time Launch Pricing: Save 40% in 2025
No hidden costs. No monthly fees. No per-user charges. Just pay for what you use.
Revolutionary pay-per-study pricing with unlimited users. Pre-purchase study bundles and lock in 2025 rates.
TFL Module: 30-day pilot, up to 3 studies ($1,500 value)
Full Suite: First complete study free ($A,000 value)
No credit card required. Keep all outputs.
| Metric | Current State | With TFL Module (Now) | With Full Suite |
|---|---|---|---|
| TFL Processing Time | 30-60 min per table | 2-5 min per table (2-20x faster) | Human-curated automation |
| Error Rate in Tables | 20% require rework | Near-zero | Near-zero |
| Protocol Development | 70hrs manual | — | 5-8hrs expert |
| CSR Creation Time (Writer Hours) | 100hrs manual | 50-70hrs (with TFL assist) | 8-12hrs expert |
| Cost per Protocol (at $150/hr labor) | $10,500 | — | $750-1,200 |
| Cost per CSR (at $150/hr labor) | $15,000 | $7,500-10,500 | $1,200-1,800 |
| Regulatory Queries (40% of studies) | 40% of studies | ~35% projected | <15% projected |
| Cost per Query | $100,000+ | $95,000 | $25,000 |
| Amendment Costs ($100k each) | $100,000+ per amendment | 5% avoided | Up to 90% avoided |
| FTE Productivity | Baseline | +100% to +800 on TFL tasks | +200-300% overall |
| User Licenses Needed | $X per user/year | Unlimited included | Unlimited included |
| ROI Timeline | — | 2-4 weeks | 4-6 weeks |
Savings based on $150/hr labor; amendments $100k (CROs) and $1-5M (sponsor) each avoided 40-90%.
| Capability | Traditional Enterprise | RegulatoryFlow | Generic AI Tools |
|---|---|---|---|
| Pricing Model | $500K-2M annual license | Pay-per-study only | Monthly subscriptions |
| User Licenses | $X per user per year | Unlimited users included | Per-seat pricing |
| Implementation | 6-12 months | 2-4 weeks | Variable |
| Training Required | Extensive (weeks) | 2 hours (Word-based) | Moderate |
| Infrastructure | On-premise or complex cloud | Secure AWS cloud | Various |
| Regulatory Compliance | Yes | Full (21 CFR Part 11) | No |
| Accuracy | Manual QC required | Near-zero errors | Inconsistent |
| Customization | Expensive add-ons | Included | Limited |
| ROI Timeline | 1-2 years | 2-4 weeks | Uncertain |
Altasciences, a fully integrated CRO/CDMO with over 30 years of excellence in early-phase drug development, chose RegulatoryFlow after rigorous evaluation. They're not just implementing our technology—they're actively shaping it through real-world training data, user testing, and continuous feedback from their frontline teams.
This isn't a vendor relationship. It's a strategic collaboration to redefine what's possible in clinical trial documentation.
See a Live Demo: Watch how medical writers save 50-200 hours per CSR with our Word-integrated workflow, achieving near-zero errors.
Schedule Demo →You're losing winnable bids because competitors promise faster timelines you can't match with current processes.
Documentation rework and amendments eat into already thin margins. One protocol amendment costs $100k-$5M. Regulatory queries average $100k+ each, affecting 40% of studies.
You can't find enough qualified medical writers. The ones you have are burned out from repetitive tasks. Per-user licensing makes scaling expensive.
Sponsors expect flawless documentation faster than ever. One error can damage relationships built over years.
With Unlimited Users and Pay-Per-Study Pricing
Our patent-pending Text Engineering technology doesn't just automate—it understands the intricate relationships between clinical data and regulatory requirements. This near-deterministic approach means consistent, accurate outputs every time, all processed in our highly secure AWS cloud environment.
TFL Module
Draft Insights Module
(In-text Results)
Protocol Creator
+ CSR Creator
Full regulatory suite
+ Submission package
Advanced Analytics
TFL module is tested and proven by Altasciences' medical writing and regulatory teams. Your first 3 studies are free to prove it yourself. No credit card required.
You know your costs: $100K+ per regulatory query, $1-5M per amendment, $150/hr medical writing labor. Our pricing: $297 per TFL study, $A,000 for full suite. Math is simple. First 3 studies free to verify.
AI guesses. Text Engineering guarantees. We use deterministic rules, not probabilistic models. Near-zero errors vs. AI hallucinations. 21 CFR Part 11 compliant vs. consumer tools.
It's just Word with superpowers - 2 hour training only. We guarantee 80% adoption in first month, or free TFL use until that bar is met. Writers actually love it because it eliminates their most tedious work.
21 CFR Part 11 compliant, SOC 2 alignment, HIPAA compliant, GDPR ready. AWS secure cloud. Your data never trains our models without explicit permission. NDA executed week 2 of implementation.
Works within Word. Exports to any system accepting Word documents. No replacement, no disruption, just enhancement. API integrations on 2026 roadmap.
Yes. Start with one therapeutic area, one team, or even one study type. Unlimited users included regardless. Most clients expand after seeing first study results.
Every month of waiting has real costs:
2-4 weeks to full production. Just deploy our Word add-in. Your secure AWS cloud backend is ready.
Works within Microsoft Word. If your team can use Word, they can master RegulatoryFlow in just 2 hours.
Dedicated success manager. Weekly optimization calls. Continuous improvement based on your feedback.
Test with 3 real TFL studies. See real results with your data. Then decide.
Join Altasciences in pioneering the future of regulatory documentation. Start with quick wins, scale to transformation.