Opprove — AI-Powered Regulatory Intelligence for Life Sciences
The regulatory intelligence platform that helps pharma, biotech, and medical device teams prepare FDA and EMA submissions faster with AI.
What is Opprove?
Opprove is an AI-powered regulatory intelligence platform purpose-built for life sciences companies navigating FDA, EMA, Health Canada, MHRA, TGA, PMDA, and 19+ global regulatory frameworks. It helps regulatory affairs professionals generate submission-ready checklists, score readiness, build regulatory pathways, and analyze compliance documents — all in one workspace.
Key Features
- Navigate — Browse agencies, offices, and jurisdictions across 19+ countries with direct links to forms and guidance.
- Regulatory Chat — Ask compliance questions in plain language and get sourced, context-aware answers instantly.
- Question Generator — Generate strategic, submission-specific questions for FDA pre-IND and pre-NDA meetings.
- Pathway Builder — Build dynamic regulatory roadmaps tailored to your product type, country, and development phase.
- Checklist Generator — Create compliance checklists from guidance documents with automatic gap identification.
- Readiness Scoring — Track submission readiness with dynamic scores tied to checklist progress and milestones.
- Feedback Integration — Analyze agency feedback letters (CRL, RTQ, RSI) and map action items to your documents.
- Guidance Engine — Search and analyze guidance documents with semantic matching and requirement-level drill-down.
- Network Graph — Visualize cross-document relationships, shared references, and similarity connections.
- Portfolio Dashboard — Track progress, gaps, and KPIs across all your programs from a single dashboard.
Who Uses Opprove?
- Regulatory consulting firms — Accelerate client deliverables with AI-powered document analysis and pathway guidance.
- Biotech and pharma startups — Navigate complex regulatory requirements without a dedicated RA department.
- Enterprise regulatory affairs teams — Unified portfolio oversight with team collaboration and project isolation.
- Academic institutions — Teach and research regulatory frameworks with AI-assisted analysis tools.
- Medical device companies — Prepare 510(k), PMA, De Novo, and EU MDR submissions with structured checklists.
Supported Regulatory Frameworks
FDA (CDER, CBER, CDRH, CFSAN, CVM), EMA, Health Canada, MHRA (UK), TGA (Australia), PMDA (Japan), NMPA (China), KFDA/MFDS (South Korea), ANVISA (Brazil), COFEPRIS (Mexico), Swissmedic, BfArM (Germany), ANSM (France), AIFA (Italy), AEMPS (Spain), HSA (Singapore), Medsafe (New Zealand), CDSCO (India), ICH guidelines (Q1-Q14, E1-E20, S1-S11, M1-M14).
Frequently Asked Questions
What is Opprove?
Opprove is an AI-powered regulatory intelligence platform that helps pharma, biotech, and medical device teams prepare FDA and EMA submissions, generate compliance checklists, score regulatory readiness, and analyze regulatory documents.
How does Opprove help with FDA submissions?
Opprove uses AI to generate tailored FDA submission checklists (IND, NDA, BLA, 510(k), PMA), score your regulatory readiness against FDA requirements, identify gaps, and provide pathway guidance based on your specific product and indication.
Does Opprove support EMA and international regulatory frameworks?
Yes. Opprove supports FDA, EMA, ICH guidelines, and regulatory frameworks from Health Canada, MHRA, TGA, PMDA, and other major global health authorities across 19+ countries.
How is Opprove different from Veeva Vault or MasterControl?
Unlike document management systems like Veeva Vault or quality management platforms like MasterControl, Opprove focuses on AI-driven regulatory intelligence: generating submission-ready checklists, scoring readiness, and providing strategic pathway guidance tailored to your product type and regulatory target.
What submission types does Opprove support?
Opprove supports IND, NDA, BLA, ANDA, 505(b)(2), 510(k), PMA, De Novo, EUA, EU MAA (centralized, decentralized, mutual recognition), biosimilar applications, combination product submissions, and orphan drug designations.
Get Started
Sign up free at opprove.app/auth — no credit card required. Free tier includes access to Navigate, Regulatory Chat, and limited AI uses per month. Professional and Team plans unlock full platform capabilities.