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Life Sciences · AI · Data

AI‑Driven Intelligence for Life Science companies Faster Answers. Better Decisions.

We help life science companies harness the power of their public and private data. By organizing and unifying vast datasets, our AI-driven platform turns complexity into clarity - empowering smarter, faster, and more confident decisions.

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21 cfr part 11 compliant Human-in-the-loop SME Verifiable links to original source documents
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What We Do

We combine the expertise of former FDA leaders, regulatory lawyers, and consultants with powerful AI-driven platforms to deliver tailored solutions that accelerate your regulatory success.

AI-Powered Regulatory Intelligence

We build advanced data platforms that automate the collection of regulatory information from multiple global sources. Instead of spending hours or days on manual research, you gain a single, unified source of truth enriched with actionable insights, cross-relational mapping, and AI-driven trend analysis that uncovers opportunities and risks others may miss.

Specialized Regulatory Consulting

Beyond software, we provide expert advisory services for complex challenges. Whether facing an unexpected compliance action that feels unjust, or navigating a trial design that is unnecessarily strict, our team delivers deep intelligence and actionable strategies to help you respond with confidence.

Industry-Specific Solutions

Tailored intelligence designed to solve your regulatory and market challenges—clearly, quickly, and credibly.

Time-Saving Intelligence

Cut research time with automated data collection and analysis across validated sources.

  • Automated data aggregation
  • AI-powered trend detection
  • Real-time visual dashboards
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Regulatory Intelligence

Stay ahead of changes with real-time monitoring of FDA/EMA activity and compliance signals.

  • Approval & submission tracking
  • Warning letter & 483 analysis
  • Risk & compliance scoring
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Competitive Intelligence

See where the market is moving with clean, decision-ready competitor insights.

  • Clinical trial monitoring
  • Pipeline & portfolio tracking
  • Market share analysis
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Client Success Stories

Leading life-sciences organizations trust SyneticX to streamline regulatory strategy and accelerate decisions.

MD

Clinical-Stage Biopharma

Biomarker-driven precision medicines

We identified inefficiencies in how guidance was applied across FDA registries, enabling a leaner trial design than originally proposed.

What we did

Analyzed regulatory precedent that had been overlooked

Outcome

Cheaper & faster trial

BI

Ultra-Orphan Drug CRL

Oncology focus

We helped the client respond to an unexpected Complete Response Letter (CRL) that felt unjust, by analysing similar precedents and crafting a targeted appeal.

Latest Insights in Healthcare Innovation

AI advances, regulatory updates, and data-driven strategies shaping the future of healthcare.

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alex@syneticx.com

How SyneticX Works

Our structured onboarding ensures rapid implementation and long-term value.

01
Introductory Call

Discovery & Assessment

We analyze your regulatory workflows, data sources, and compliance requirements to design a tailored solution.

  • Workflow mapping
  • Requirements gathering
  • Integration planning
02
Week 1–2

Custom Configuration

We configure the platform to align with your requirements, including dashboards, alerts, and workflow automation.

  • Dashboard customization
  • Alert rules
  • Data source integration
03
Deployment

Training & Launch

We deliver comprehensive training and phased deployment to ensure smooth adoption across your teams.

  • Team training sessions
  • Documentation delivery
  • Go-live support
04
Ongoing

Continuous Optimization

We provide regular reviews and updates to ensure the platform evolves with your business needs.

  • Quarterly business reviews
  • Performance optimization
  • Feature updates

Comprehensive Regulatory Intelligence Platform

Unify your regulatory operations with an integrated suite of intelligent monitoring and analytics capabilities.

FDA Submission Tracking

Monitor submissions, amendments, and correspondence in real time — with automated alerts for deadlines and regulatory changes.

Competitive Intelligence

Track competitor regulatory activities, product pipelines, and positioning — with predictive analytics for strategy.

Clinical Trial Analytics

Global trial analysis, enrollment metrics, and protocol optimization recommendations at your fingertips.

Real-Time Alerts

Custom alerts for regulatory changes, competitor activities, and compliance deadlines worldwide.

Custom Solutions

Tailored modules and integrations to fit unique regulatory and operational needs.

Have Something in Mind?

Need historical FDA precedent or custom analytics? Our team can support your unique challenges.

Enterprise-Ready Integration Ecosystem

Connect seamlessly with your existing regulatory, compliance, and quality management systems.