The Prevantic
Product Ecosystem

Precision-engineered AI tools for every stage of the clinical and regulatory submission lifecycle.

The Core Engine

Clinical Study Report (CSR) Automation

From Protocol + SAP to complete CSR in seconds. Automate the most time-consuming parts of your regulatory submissions.

Protocol Synthesis

Automated ingestion of clinical protocols for document skeletal mapping.

GxP Traceability

Word-level links between generated narratives and source biostats.

TLF Integration

Seamless conversion of Tables, Listings, and Figures into text.

Ready-to-File

Outputs formatted for immediate submission to global bodies.

Clinical Protocol v2.4
Statistical Analysis Plan (SAP)
Validated TLF Outputs
Generating CSR Narrative...
Section 6.1: Subject Disposition
Section 11.2: Efficacy Analysis
Audit Trail: 100% Traceability
Submission Accelerator

CTD Submission Suite

Accelerate your Common Technical Document submissions. From literature search for Module 5 to Module 2 summaries.

Literature Mining

AI scans PubMed and journals for drug-specific evidence.

Scale Ingestion

Process thousands of pages of raw data in minutes.

Cross-Refs

Automatic hyperlinking between Module 2 and Module 5.

ANDA Optimized

Specialized workflows for fast-track drug approvals.

Drug Compound Database
15,000+ Internal Records
PubMed API Live Stream
Literature Synthesis & Mapping...
Module 5: Literature Map
Module 2.3: Quality Summary
Automated Cross-Reference Log
The Strategy Layer

Regulatory Analytics & Intelligence

Predictive insights for global market access and compliance risk. Monitor shifts in global standards in real-time.

Horizon Scanning

Real-time tracking of FDA, EMA, and MFDS guideline updates.

Market Mapping

Optimal submission paths mapped across 40+ countries.

Risk Profiling

AI-driven assessment of submission success probabilities.

Compliance Shield

Continuous monitoring for GxP and GDPR drift.

FDA Draft Guidance 2025
EMA Post-Market Data
Country Access Metrics
Global Compliance Risk Assessment...
Risk Score: 98.4% Submission Ready
Market Access Roadmap: EU/KR/JP
Compliance Drift Alert: Nominal

Built for the Global Gold Standard

Whether you're a Top 10 Pharma or a stealth biotech, Prevantic secures your path to market with enterprise-grade data sovereignty.