RegulaVita

Intelligent Pharmaceutical Compliance Solutions

Transform your regulatory workflows with AI that delivers faster, more accurate, and cost-effective compliance processing

90%+
Cost Reduction
10x
Faster Processing
100%
Compliant

AI-Augmented Pharmacovigilance Management

Core Functionality

AI agents automate PV case intake and response generation with deep research over trusted sources (SMPCs, PubMed, EMBASE), handling digitalization, structuring, and drafting end-to-end with human-in-the-loop validation

Reliability

100% compliance with ICH E2B(R3) and FDA 21 CFR Part 314.80. GxP and GAMP5 validation-ready with full audit traceability and inspection-ready decision review for every AI activity

Economics

Process cases in <5 minutes vs. 8.3 hours (>99% faster). Reduce per-case costs from $33 to under $3 (90%+ savings)

Implementation

SaaS platform with secure email and API-based integration. Rapid implementation with iterative MVPs, fallback options, and seamless connectivity to EudraVigilance, FDA FAERS, and case management systems

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IDMP Data Extraction

Core Functionality

AI agents automatically extract and structure IDMP-compliant data from unstructured regulatory documents, handling complex document processing workflows autonomously

Reliability

Impressive high quality extraction with validation against regulator-defined schemas, ensuring data accuracy and regulatory compliance

Economics

Outstanding ROI with 90%+ reduction in manual data entry costs, faster time-to-market, and elimination of costly data quality issues

Implementation Options

Internal: Static binaries for air-gapped data centers with full control. External: Cloud-based SaaS deployment

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Ready to Transform Your Compliance Operations?

Connect with us on LinkedIn and let's discuss how we can help streamline your pharmaceutical compliance workflows with AI

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GAMP-5 Compliant
21 CFR Part 11
ICH Guidelines

Cutting-Edge Technology

Our platform is built on the latest advances in artificial intelligence and machine learning. We leverage state-of-the-art multimodal large language models, fine-tuned specifically for life science and pharmaceutical applications.

What we use

Vision-language models capable of understanding complex document layouts, medical terminology, and regulatory requirements. Our systems are trained on extensive pharmaceutical datasets to ensure domain expertise.

How we calibrate

Continuous calibration using real-world regulatory data, expert validation, and feedback loops. Our models undergo rigorous testing against gold-standard datasets and regulatory requirements.

Outstanding reliability

We achieve human-level accuracy in document processing and information extraction, with built-in validation mechanisms and quality checks at every step.

Performance at scale

Process documents in minutes instead of hours, with throughput that scales linearly with your needs. Our infrastructure handles surge capacity during critical regulatory deadlines.

Quality is Non-Negotiable

In pharmaceutical and life science operations, quality is not optional: regulatory compliance, patient safety, and data integrity are non-negotiable requirements that we take extremely seriously.

Our Quality-First Principles

✓

Validation and verification

Every output is validated against regulatory requirements and quality standards

✓

Traceability

Complete audit trails for all processing steps, ensuring full transparency and accountability

✓

Human oversight

AI-augmented workflows that keep humans in the loop for critical decisions

✓

Continuous monitoring

Real-time quality metrics and alerts to ensure consistent performance

✓

Regulatory compliance

Built to meet GAMP-5, 21 CFR Part 11, ICH guidelines, and other relevant standards

We don't compromise on quality. Our technology is designed to meet and exceed the stringent requirements of pharmaceutical operations, ensuring that every process, every document, and every data point meets the highest standards of accuracy and compliance.