Smarter Decisions. Regulatory Clarity. One Platform

5010AI combines deep analytics and purpose-built AI to help drug development teams move faster, with confidence.

Unlock the Potential of Artificial Intelligence

Unlock the Potential of Artificial Intelligence

Featured Products

For the drug development industry

Save Over 90% of Regulatory Research Time

5010 Analytics gives you instant access to critical FDA and EMA precedent via our Nexus platform — eliminating the guesswork from regulatory strategy. By combining the precision of AI with the insight of expert curation, we deliver high-value datasets focused on approved oncology products and beyond.

Our regulatory intelligence system helps teams move faster, align decisions, and focus on what matters most.

AI Trained Specifically on Regulatory Documents

Our AI solution is purpose-built for regulatory strategy — trained on approval documents and guidance to deliver precise, context-aware insights. Developed in partnership with leading AI innovators, it’s designed to reduce hallucinations and support faster, more informed decision-making.

Currently in development, this product will bring the power of domain-trained AI to regulatory teams of all sizes.

How Teams Use 5010AI

Save 90%+ of Time in Precedent Hunting

Instantly identify and export all NSCLC approvals that used progression-free survival (PFS) as a primary endpoint — in under a minute.


(Time saved: ~5 hours per search)

Interrogate Precedent with AI

Ask targeted questions — like “Has ORR ever been accepted as a primary endpoint for traditional approval in rare hematologic diseases?” — and get document-backed, context-aware answers from AI trained on approval data

Get the Complete Picture - Instantly

Explore approved indications across drug classes, filter by line of therapy, and run free-text searches on expert-curated benefit–risk summaries — all in minutes.


(Time saved: ~7 hours per review)

Testimonials

  • 5010 Analytics saves us hours on precedent searching - it is perfect for our needs.

    Senior Director, Global Regulatory Strategy (large Biotech, Oncology)

  • We found some fascinating details that we could build into our strategy, as a small biotech this is incredibly helpful.

    VP, Regulatory Affairs (pre-revenue Biotech, Oncology)

  • The time save is real! I also greatly appreciate how simple the tool is to use, click, click answers.

    Associate Director, Regulatory Intelligence (Global Big Pharma, Top 10 Oncology)

  • This offering at this price point was a no-brainer for us.

    SVP, Regulatory Affairs (pre-revenue Biotech, Oncology)

Contact Us

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