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.
"This database has proven to be an invaluable resource, offering reliable, well-curated information that greatly enhances decision-making and our communication with regulatory agencies and partners."
We combine the expertise of former FDA leaders, regulatory lawyers, and consultants with powerful AI-driven platforms to deliver tailored solutions for pharmaceutical companies. We help you bring therapies to market faster, minimize compliance risks, and navigate FDA interactions with confidence.
We build advanced regulatory intelligence platforms that automate the collection and analysis of FDA, EMA, and global regulatory data from multiple authoritative sources.
Instead of spending hours or days manually researching CRLs, approval pathways, or label changes, you gain instant access to a unified, AI-powered system that aggregates all public sources - delivering verifiable insights in seconds, not weeks.
Beyond regulatory data, we deliver custom business intelligence dashboards that give you complete visibility into competitor activity, market dynamics, and commercial signals. Track competitor financials, clinical trial pipelines, reimbursement landscapes, PBM relationships, and share-of-voice - all unified in secure, real-time dashboards tailored to your therapeutic area.
Member of the NVIDIA Connect Program
Tailored intelligence designed to solve your regulatory and market challenges—clearly, quickly, and credibly.
Cut research time with automated data collection and analysis across validated sources.
Stay ahead of changes with real-time monitoring of FDA/EMA activity and compliance signals.
See where the market is moving with clean, decision-ready competitor insights.
Leading life-sciences organizations trust SyneticX to streamline regulatory strategy and accelerate decisions.
Global Pharmaceutical
Top-10 pharma
“SyneticX reduced our NDA preparation time by 45% and surfaced critical competitive insights that shaped our market entry.”
Time saved
45%
ROI
320%
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
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.
AI advances, regulatory updates, and data-driven strategies shaping the future of healthcare.
Featured
Pipeline & Portfolio Analysis
Market Analysis
In-depth forecast of U.S. drug pricing, supply chains, and competitive positioning under new tariff structures.
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Global Markets
How international markets, regulators, and manufacturers are preparing for ripple effects from U.S. tariff escalation.
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Pharma Analysis
A sector breakdown of UK-listed pharma firms most vulnerable to U.S. trade actions, with implications for investors.
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AI & Diagnostics
How AI improves accuracy across radiology, pathology, and genomics—enabling earlier detection and personalized care.
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Regulatory Update
What MedTech teams need to know about policy changes, SaMD expectations, and practical approval strategies.
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Data Analytics
How leading systems allocate resources, cut readmissions, and improve outcomes using predictive models.
Read Full ArticleAI advances, regulatory updates, and data-driven strategies shaping the future of healthcare.
Market Analysis
In-depth forecast of U.S. drug pricing, supply chains, and competitive positioning under new tariff structures.
Read Full Article
Global Markets
How international markets, regulators, and manufacturers are preparing for ripple effects from U.S. tariff escalation.
Read Full Article
Pharma Analysis
A sector breakdown of UK-listed pharma firms most vulnerable to U.S. trade actions, with implications for investors.
Read Full Article
AI & Diagnostics
How AI improves accuracy across radiology, pathology, and genomics—enabling earlier detection and personalized care.
Read Full Article
Regulatory Update
What MedTech teams need to know about policy changes, SaMD expectations, and practical approval strategies.
Read Full Article
Data Analytics
How leading systems allocate resources, cut readmissions, and improve outcomes using predictive models.
Read Full Article
Learn what a 505(b)(2) NDA is, why companies choose this hybrid FDA pathway, and how it accelerates approval by using existing data.
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Regulatory Strategy
Understand the real cost, timeline, and risks of a 505(b)(2) submission and how data-driven planning can improve FDA success rates.
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Data Intelligence
Learn how connected regulatory and clinical data can reduce risk in 505(b)(2) submissions and help teams make confident FDA decisions.
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Regulatory Pathway
Understand the traditional NDA pathway, its challenges, and why pharmaceutical companies are exploring alternative regulatory routes.
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Policy Impact
What sponsors should know about deadlines, delays, and planning strategies during federal government shutdowns.
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AI Innovation
Explore how artificial intelligence is transforming regulatory submissions, pharmacovigilance, and the future of regulatory professionals.
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Competitive Intelligence
In-depth pipeline and portfolio analysis covering Pfizer's therapeutic strategy, regulatory milestones, and competitive positioning for 2026.
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Competitive Intelligence
Comprehensive analysis of Novartis' patent cliff exposure, radioligand therapy expansion, pipeline catalysts, and strategic positioning through 2026.
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Competitive Intelligence
Strategic analysis of GSK's HIV franchise transition, vaccine leadership with Shingrix and Arexvy, pipeline momentum under Emma Walmsley, and regulatory outlook.
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Get in touch to see how SyneticX can transform your regulatory operations
Prefer to email directly?
alex@syneticx.comTailored intelligence solutions designed for your specific regulatory challenges
Cut research time with automated data collection and analysis across multiple sources.
Stay ahead of regulatory changes with real-time monitoring of FDA approvals.
Gain vital insights into competitor activities and strategic movements.
Leading life sciences organizations trust SyneticX to transform their regulatory operations
Global Pharmaceutical
Top 10 Pharma
"SyneticX reduced our NDA preparation time by 45% and helped us identify critical competitive intelligence that shaped our market entry strategy."
Time Saved
45%
ROI
320%
Clinical-Stage Biopharmaceutical company
biomarker-driven precision medicines
"We uncovered inefficienceies in gudance usage by fda registys that lead to a much more leniant trial design compared to what the fda initially said "
Analysing regulatory precedent that the fda didnt even know themsleves
Value Saved
Cheaper and faster trial
Biotech Innovator
Oncology Focus
"SyneticX's competitive intelligence capabilities gave us crucial insights that accelerated our breakthrough therapy designation."
Time to BTD
-3 months
Market
First-in-class
Explore cutting-edge developments in medical AI, regulatory updates, and transformative technologies shaping the future of healthcare
AI & Diagnostics
Discover how artificial intelligence is transforming diagnostic accuracy across radiology, pathology, and genomics, enabling earlier disease detection and personalized treatment strategies.
Regulatory Update
An in-depth analysis of the current regulatory landscape for AI-powered medical devices, including recent policy changes and what MedTech companies need to know for successful approvals.
Data Analytics
Learn how leading healthcare institutions leverage predictive models to optimize resource allocation, reduce readmissions, and improve patient outcomes through data-driven insights.
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3–5 quick fields. We’ll follow up with scheduling options.
Our proven implementation process ensures rapid time-to-value
We conduct a comprehensive analysis of your regulatory workflows, data sources, and compliance requirements to design a tailored solution.
We configure the platform to match your specific needs, including custom dashboards, alert rules, and automated workflows.
Comprehensive training for your team and phased deployment to ensure smooth adoption across your organization.
Regular reviews and updates to ensure the platform continues to deliver maximum value as your needs evolve.
Our structured onboarding ensures rapid implementation and long-term value.
We analyze your regulatory workflows, data sources, and compliance requirements to design a tailored solution.
We configure the platform to align with your requirements, including dashboards, alerts, and workflow automation.
We deliver comprehensive training and phased deployment to ensure smooth adoption across your teams.
We provide regular reviews and updates to ensure the platform evolves with your business needs.
Track drug development from molecule to market. Our platform integrates ChEMBL's comprehensive molecular database with real-time regulatory intelligence, providing unprecedented insights into competitive drug landscapes.
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C27H35N6O8P
MW
602.6 Da
Phase
Marketed
Targets
RNA Pol
Unify your regulatory operations with an integrated suite of intelligent monitoring and analytics capabilities.
Monitor submissions, amendments, and correspondence in real time — with automated alerts for deadlines and regulatory changes.
Track competitor regulatory activities, product pipelines, and positioning — with predictive analytics for strategy.
Global trial analysis, enrollment metrics, and protocol optimization recommendations at your fingertips.
Custom alerts for regulatory changes, competitor activities, and compliance deadlines worldwide.
Tailored modules and integrations to fit unique regulatory and operational needs.
Need historical FDA precedent or custom analytics? Our team can support your unique challenges.
Unify your regulatory operations with our integrated suite of intelligent monitoring and analytics capabilities
Monitor all FDA submissions, amendments, and correspondence in real-time. Automated alerts for critical deadlines and regulatory changes.
Track competitor regulatory activities, product pipelines, and market positioning. Predictive analytics for strategic planning.
Comprehensive analysis of global clinical trials, enrollment metrics, and protocol optimization recommendations.
Customizable alert system for regulatory changes, competitor activities, and compliance deadlines across all jurisdictions.
If you need a tailored solution, we can build custom modules and integrations to fit your unique regulatory needs.
We can help you save time and/or analyse historical FDA market precedent. Let’s explore how our team can support your unique challenges.
Join industry leaders and regulatory experts for insights that drive innovation
How Regulatory Intelligence Helps Pharma Leaders Move Faster in 2025
Registration Closes In
What You'll Learn:
Navigate the complexities of European medical device regulation with expert guidance.
Learn more →Industry leaders discuss the transformative role of AI in accelerating clinical development.
Learn more →Advanced techniques for tracking and analyzing competitor regulatory activities.
Learn more →Stay connected with industry leaders and regulatory experts
How Regulatory Intelligence Helps Pharma Leaders Move Faster in 2025
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Seamlessly integrate with your existing regulatory and quality management systems
Connect seamlessly with your existing regulatory, compliance, and quality management systems.
Get a personalized walkthrough of how our platform can transform your regulatory operations.
Your demo request has been received. Our team will contact you within 24 hours.
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30-minute demo tailored to your specific regulatory challenges
Direct access to our regulatory experts to answer your questions
Custom assessment of potential time and cost savings for your organization
Clear path to deployment with timeline and resource requirements
Industry experts dedicated to transforming regulatory intelligence
Advisor and Investor
Mark is a seasoned FDA regulatory attorney and former regulatory counsel within the Office of Compliance at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). With more than two decades of experience spanning government, industry, and private practice, he has advised global pharmaceutical companies, trade associations, and emerging innovators on complex regulatory, compliance, and international market issues. Based in Kentucky, Mark is the founder of White Oak AI Law, where he focuses on the intersection of life sciences and artificial intelligence. As both an advisor and investor in our company, he brings unparalleled insight into FDA regulatory pathways, compliance strategy, and the evolving landscape of biopharma innovation.
Co-Founder
Rohan has a background in computer science and economics, with a focus on building AI systems that improve efficiency across life sciences while maintaining accuracy and precision. Passionate about shortening development timelines through automated research treatments reach patients faster.
Co-Founder
Strong foundation in mathematics and computer science, solving complex challenges in life sciences. Passionate about applying AI to uncover insights from difficult-to-access data for sharper, faster decisions.
Advisor and Investor
Mark is a seasoned FDA regulatory attorney and former counsel at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). With more than two decades of experience spanning government, industry, and private practice, he has advised global pharmaceutical companies, trade associations, and emerging innovators on complex regulatory, compliance, and international market issues. Based in Kentucky, Mark is the founder of White Oak AI Law, where he focuses on the intersection of life sciences and artificial intelligence. As both an advisor and investor in our company, he brings unparalleled insight into FDA regulatory pathways, compliance strategy, and the evolving landscape of biopharma innovation.
Co-Founder
Rohan has a background in computer science and economics, with a focus on building AI systems that improve efficiency across life sciences while maintaining accuracy and precision. Passionate about shortening development timelines through automated research so treatments reach patients faster.
Co-Founder
Alexander brings a strong foundation in mathematics and computer science to solving some of the most complex challenges in life sciences and technology. Passionate about applying AI to uncover insights from difficult-to-access data and has built tools that help leaders make sharper, faster decisions.
Advisor and Investor
Mark is a seasoned FDA regulatory attorney and former regulatory counsel within the Office of Compliance at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). With more than two decades of experience spanning government, industry, and private practice, he has advised global pharmaceutical companies, trade associations, and emerging innovators on complex regulatory, compliance, and international market issues. Based in Kentucky, Mark is the founder of White Oak AI Law, where he focuses on the intersection of life sciences and artificial intelligence. As both an advisor and investor in our company, he brings unparalleled insight into FDA regulatory pathways, compliance strategy, and the evolving landscape of biopharma innovation.
Co-Founder
Rohan has a background in computer science and economics, with a focus on building AI systems that improve efficiency across life sciences while maintaining accuracy and precision. Passionate about shortening development timelines through automated research treatments reach patients faster.
Co-Founder
Strong foundation in mathematics and computer science, solving complex challenges in life sciences. Passionate about applying AI to uncover insights from difficult-to-access data for sharper, faster decisions.
Industry experts dedicated to transforming regulatory intelligence
Advisor and Investor
Mark is a seasoned FDA regulatory attorney and former counsel at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). With more than two decades of experience spanning government, industry, and private practice, he has advised global pharmaceutical companies, trade associations, and emerging innovators on complex regulatory, compliance, and international market issues. Based in Kentucky, Mark is the founder of White Oak AI Law, where he focuses on the intersection of life sciences and artificial intelligence. As both an advisor and investor in our company, he brings unparalleled insight into FDA regulatory pathways, compliance strategy, and the evolving landscape of biopharma innovation.
Co-Founder
Rohan brings a background in computer science and economics, with a focus on building AI systems that improve efficiency across the life sciences. Passionate about the good AI can do, he is driven by the mission of accelerating critical processes so that life-saving treatments can reach patients faster.
Co-Founder
Alexander brings a strong foundation in mathematics and computer science to solving some of the most complex challenges in life sciences and technology. Passionate about applying AI to uncover insights from difficult-to-access data and has built tools that help leaders make sharper, faster decisions.
Schedule an executive briefing to explore how SyneticX can accelerate your regulatory timelines and reduce compliance risk.
Schedule an executive briefing and discover how SyneticX can accelerate regulatory timelines and reduce compliance risk.
