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Accelerate Growth Without Risking Compliance

Unify third-party risk, contracts, and spend across your biotech supply chain

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Keep Trials and Funding on Track, Automatically

Delays, non-compliance and supplier failure risk more than timelines. They threaten regulatory inspections and capital.

Gatekeeper surfaces key dates, risks and deliverables across your entire biotech portfolio. Our LuminIQ AI agents monitor every supplier and contract milestone, so you can act before risk becomes disruption.

Stay audit-ready. Hit every deadline. Protect every investment.

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Speed Up Biotech Approvals Without Risking Compliance or Audit Failure

Manual contract approvals risk MHRA breaches, missed milestones and inspection delays.

Gatekeeper replaces inconsistent sign-off processes with AI-powered, best practice workflows. Tailored by value, risk and document type, nothing gets missed and every approver is accountable.

Create an automated audit trail from first draft to signature. Reduce turnaround times. Prove compliance at every step.


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Secure IP, Accelerate Deals, and Stay Compliant with QES

High-stakes agreements, from licensing and IP rights to CRO contracts, demand both speed and regulatory certainty.

Gatekeeper supports Qualified Electronic Signatures (QES) to meet global standards like eIDAS. Every signature is fully traceable, tamper-proof, and audit-ready, accelerating contract approvals without compromising compliance.

Close faster, stay compliant, and safeguard your most valuable research assets.

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See Gatekeeper in action

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Protect Clinical Trials and IP with Always-On Global Compliance


Protect your clinical trials and IP by automating third-party compliance across your biotech portfolio.

Our AI Agents continuously surface risks, financial changes, and cybersecurity threats in your supply chain, before they threaten inspections or disrupt funding.

Monitor every contract and supplier agreement against FDA, EMA, REACH, and USPTO standards in one auditable, inspection-ready system.

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Avoid Penalties and Prevent Auto-Renewals

Every missed renewal risks late-stage trial delays, stalled production, or IP exposure. With Gatekeeper, you stay ahead of every agreement across your CDMOs, CROs, and supply chain.

Our AI Agents surface upcoming renewals, helping you to renegotiate proactively and prevent costly disruptions before they happen.

Avoid penalties, renegotiate smarter, and protect continuity across your research operations.

Gatekeeper HELPS BIOTECH FIRMS to: 

 

  • Reduce regulatory risk: LuminIQ Agents centralise and monitor clinical, manufacturing, and IP agreements in a single, compliant workspace.
  • Accelerate partnerships and trials: Secure digital signatures and AI-driven workflows help you finalise CRO, CDMO, and licensing contracts faster.
  • Maintain inspection readiness: Agents track and manage third-party compliance gaps automatically, no chasing or last-minute scrambles.
  • Enforce internal controls: Route high-value approvals through auditable, best-practice workflows and AI Agents.
  • Protect research timelines: Avoid delays by tracking key renewal dates and renegotiating terms early
  • Simplify due diligence: Instantly access contract data, approvals, and audit trails to support regulatory reviews, funding rounds, or M&A.