AI-driven platform automating clinical trial documentation compliance for pharma companies. Reduces submission errors by 30% and speeds processes by 40%. Targets $8.2B regulatory tech market with tiered SaaS model.
PharmaComply addresses the critical bottleneck in drug development – regulatory submissions – through AI-powered document verification. By automatically detecting inconsistencies and compliance gaps in clinical trial documentation, it accelerates time-to-market while reducing costly submission errors. Designed specifically for mid-sized pharma and biotech companies navigating complex FDA/EMA requirements.
Core functionality
Automated document verification for clinical trial submissions using NLP to detect inconsistencies, missing data, and compliance gaps in real-time. Features include FDA/EMA template alignment, version control, audit trail generation, and risk-scoring of submission packages.
Target user and segment
Regulatory affairs teams in mid-sized pharma companies ($50M-$500M revenue) and biotech startups conducting Phase 2-3 clinical trials. Secondary users include CROs managing submissions for multiple clients.
Recommended tech stack
- Python/TensorFlow for NLP models
- React.js dashboard
- Node.js backend
- PostgreSQL for document metadata
- AWS SageMaker for model training
- HIPAA-compliant Azure cloud infrastructure
Estimated MVP hours and costs
- Frontend: 200h (€20,000)
- Backend: 180h (€18,000)
- NLP Engine: 300h (€30,000)
- Compliance DB: 120h (€12,000)
- Testing: 100h (€10,000)
Total development: €90,000 + €3,500/month cloud infrastructure
SWOT-analysis
- Strengths: 40% faster submissions, 30% error reduction
- Weaknesses: Requires regulatory expert training data
- Opportunities: Expansion to medical device/IVD markets
- Threats: Veeva Vault Regulatory dominance
First 1000 customers strategy
- Content partnerships with DIA/TOPRA associations (€20k)
- LinkedIn ads targeting regulatory directors (€150 CPA)
- Freemium document scanner tool
- Conference sponsorships (Bio-Europe, DIA Global)
Total acquisition cost: €225k at 4% conversion rate
Monetization
Tiered SaaS: Basic (€1,500/mo), Pro (€4,000/mo), Enterprise (€10,000+/mo)
Break-even: 55 Pro subscribers covering core costs
Core team: 1 PM, 2 full-stack devs, 1 NLP specialist, 0.5 FTE regulatory advisor
Market positioning and competitors
$8.2B regulatory tech market growing at 12.4% CAGR. Competitors include Veeva Vault (enterprise focus) and DocuSign CLM. Initial focus on EU biotech hubs with oncology-specific rule sets as key differentiator.
