AI-Powered FDA Compliance Software and Regulatory Intelligence Platform
ARCS Scientific builds AI compliance automation tools that help healthcare organizations, medical device companies, and pharmaceutical firms stay ahead of FDA regulations. Our platform monitors regulatory changes in real time across 50+ countries and turns complex compliance requirements into clear action steps.
Automated Regulatory Compliance for Healthcare and Life Sciences
Getting FDA approval takes too long when you're tracking regulations manually. ARCS Scientific automates the hardest parts of regulatory compliance so your team can focus on innovation instead of paperwork. We help companies in healthcare, biotech, and medical devices navigate FDA 21 CFR Part 11, HIPAA, GDPR, and ISO 13485 requirements without hiring more compliance staff.
Our platform scans regulatory updates from FDA, EMA, and other global health authorities every day. When a new rule affects your products or trials, you get an alert with specific recommendations. This saves months of research time and reduces the risk of costly violations or delayed submissions.
What ARCS Scientific Does for Your Compliance Team
FDA Submission Automation
Prepare 510(k) submissions, IDE applications, and PMA filings faster with AI-assisted document generation. Our system checks your submission against FDA requirements before you send it.
Real-Time Regulatory Monitoring
Track changes to FDA guidance documents, EU MDR updates, and HIPAA rules as they happen. Get alerts when new regulations affect your products or clinical trials.
HIPAA and GDPR Compliance Tools
Maintain patient privacy and data security with automated compliance checks. Our platform monitors your systems for HIPAA violations and helps you meet GDPR requirements for clinical data.
ESG Reporting for Healthcare
Generate ESG compliance reports that meet SEC, ISSB, and CSRD standards. Track sustainability metrics and prove your environmental commitments to investors and regulators.
Clinical Trial Compliance
Stay compliant with ICH-GCP guidelines and 21 CFR Part 312. Monitor trial protocols for regulatory issues before they become problems with your IRB or FDA inspectors.
Multi-Country Regulatory Intelligence
Plan your global market entry strategy with compliance intelligence from 50+ countries. Know exactly what paperwork you need for each market before you start the approval process.
Who Uses ARCS Scientific
Medical device manufacturers use our platform to speed up FDA 510(k) submissions and track post-market surveillance requirements. Pharmaceutical companies rely on ARCS for clinical trial compliance and IND application support. Healthcare systems use our tools to maintain HIPAA compliance and prepare for Joint Commission audits.
We also work with biotech startups navigating their first FDA submission, CROs managing multi-site clinical trials, and digital health companies building HIPAA-compliant apps. Financial institutions use ARCS for AML compliance and sanctions screening. Government agencies rely on our platform for critical infrastructure protection and policy analysis.
Why Companies Choose ARCS Over Traditional Compliance Software
- ✓ Predictive alerts before regulations change: Most compliance tools tell you about new rules after they're published. ARCS analyzes regulatory trends and predicts upcoming changes so you can prepare months in advance.
- ✓ Built for complex multi-country operations: If you're selling medical devices in the US, EU, and Asia, you need compliance intelligence that works across all those markets. ARCS handles it automatically.
- ✓ AI that understands regulatory language: Our system reads FDA guidance documents and extracts the specific requirements that apply to your products. No more spending hours interpreting dense regulatory text.
- ✓ Scenario testing before you submit: Run simulations to see how regulatory changes affect your compliance status. Test different strategies before committing to expensive process changes.
- ✓ Complete audit trail for inspections: Every decision and recommendation in ARCS is logged with cryptographic verification. Show FDA inspectors exactly how you maintained compliance over time.
About James Scott, Founder of ARCS Scientific
James Scott built ARCS Scientific after working with regulatory agencies and healthcare companies in over 50 countries. He saw how much time companies waste on compliance tasks that computers could handle better. His background in systems architecture and AI research led him to create software that actually understands regulatory requirements instead of just storing documents.
Before starting ARCS, James developed compliance systems for government agencies, financial institutions, and medical device manufacturers. He's advised central banks on regulatory technology and helped NGOs navigate complex legal frameworks in conflict zones. His work focuses on making compliance faster and more reliable through better technology.
Ready to Automate Your Regulatory Compliance?
See how ARCS Scientific can cut your compliance workload by 60% and help you submit to FDA faster. Book a demo to see the platform in action with your actual regulatory requirements.
Get Started with ARCS