Problem

The Current Manual Processes in the Pharmaceutical or Biotech Industry Creates Significant Barriers

Manual processes delay efficient drug development and regulatory compliance, ultimately preventing life-saving treatments from reaching patients.

Our Mission

Never before in history have we had the power to use autonomous workflows to accelerate life-saving treatments—but now, AI is changing everything.

We are revolutionizing regulatory compliance with cutting-edge automation, enabling businesses to achieve faster, more precise FDA alignment.

Because in the fight against rare diseases, delays cost lives.Innovation isn't optional—it's the breakthrough the world has been waiting for.

See It In Action

Potential Savings

Why This Workbench is a Game Changer?

$6.2M-$10.6M

over five years, revolutionizing biotech efficiency and ROI

AI-DRIVEN ASSISTANCE

$800K-$1.2M

Saves over five years by automating repetitive tasks

REAL-TIME INSIGHTS

$1M-$1.5M

Speeds decision-making, saving in opportunity costs

ENHANCED COMPLIANCE

$2M-$4M

Avoids fines and delays, saving over five years

COST & TIME EFFICIENCY

$1.5M-$2.5M

Accelerates time-to-market, saving in launch costs

Market Size

Potential Partners Ready for Integration

2,153

San Diego Life Sciences Companies

3,638

Bay Area Life Sciences Companies

Strategic Partners

Leading companies ready to revolutionize biotech efficiency

Security & Compliance

Mednova.ai maintains strict adherence to global regulatory standards, ensuring the highest level of data protection and compliance.

Technical and Regulatory Highlights

🔒
End-to-End Encryption
AES-256 encryption aligned with FDA guidelines and HIPAA requirements.
🛡️
AI-Based Threat Detection
Real-time anomaly detection compliant with cybersecurity standards in healthcare.
🔐
Access Controls (RBAC & ABAC)
Rigorous controls supporting FDA 21 CFR Part 11, GDPR, and EMA regulatory expectations.

Future Roadmap

🎯
Zero Trust Security
Further compliance with evolving FDA cybersecurity frameworks.
📋
Automated Regulatory Compliance
Efficient management of submissions for FDA, EMA, and other regulatory bodies.
⛓️
Blockchain Audit Trails
Enhancing auditability and regulatory transparency in data management.

Ready to Transform Your Regulatory Process?

Join the revolution in pharmaceutical compliance automation

Schedule a Demo