Own the source code. Deploy autonomous agents. Protect your IP. Built for GxP, FDA 21 CFR Part 11, and the most regulated environments in the world.
ibl.ai is a production-grade AI platform serving 1.6M+ users across 400+ organizations — delivered as full source code, not a SaaS subscription. Pharmaceutical and biotech organizations receive the complete codebase, deploy it on their own infrastructure, and operate it with zero external dependencies.
This is not a pilot project or a proof of concept. It is a validated, production platform that powers AI at scale for NVIDIA, Kaplan, and leading global institutions — now purpose-built for the compliance, IP protection, and data integrity demands of pharma and biotech.
From autonomous agents that monitor clinical trial deviations to AI-driven regulatory document generation and GxP training compliance, ibl.ai gives your organization the infrastructure to move faster without compromising the auditability, security, or control that FDA and EMA regulations demand.
1.6M+ users across 400+ organizations including NVIDIA, Kaplan, and Syracuse University. This platform has been stress-tested in production environments — not assembled for a demo.
You receive the complete codebase. No black-box SaaS. No runtime dependencies on ibl.ai servers. Your legal, compliance, and engineering teams can audit, validate, and modify every line.
Run on your private cloud, on-premise data center, or fully air-gapped environment. Zero data leaves your perimeter. Ideal for environments governed by FDA 21 CFR Part 11 and GxP requirements.
Works with Claude, GPT-4, Gemini, Llama, Mistral, or your own fine-tuned models. Swap or upgrade models without rebuilding your platform. No model vendor lock-in.
If you never call us again, the system keeps running. You own the platform, the data, the agents, and the infrastructure. No license renewals. No forced upgrades. No dependency.
Every agent decision, action, API call, and data query is logged and reviewable. Built for environments where auditability is not optional — it is a regulatory requirement.
Agents autonomously draft, review, and cross-reference regulatory submissions — CTDs, INDs, NDAs — by querying internal document repositories, applying current FDA and EMA guidance, and flagging inconsistencies before human review. Agents do not wait to be asked; they monitor document pipelines and act.
Autonomous agents continuously monitor trial data feeds, protocol adherence logs, and site reports. When a deviation threshold is crossed, agents classify severity, generate CAPA documentation drafts, notify responsible parties, and log the full action chain — without human initiation.
Agents track training completion across roles, sites, and SOPs. When a qualification gap is detected — new SOP release, role change, expiring certification — agents automatically assign training, send escalations, and update compliance records. Full audit trail maintained for inspection readiness.
Agents autonomously scan PubMed, internal research databases, and patent repositories to surface relevant findings, identify compound interactions, and synthesize competitive intelligence reports. Agents execute searches, analyze results, and deliver structured summaries — not search links.
Agents monitor adverse event databases, incoming safety reports, and post-market surveillance data in real time. When a potential safety signal emerges, agents correlate across data sources, generate preliminary signal assessment reports, and route to the appropriate safety officer with full evidence chains.
MentorAI-powered agents deliver role-specific onboarding for clinical, regulatory, and manufacturing staff — adapting content to the learner's role, site, and current SOP version. Agents track competency, flag gaps, and generate training records compliant with 21 CFR Part 11 electronic signature requirements.
Traditional chatbots answer questions. Autonomous AI agents take action, reason over context, and deliver measurable outcomes.
ibl.ai deploys autonomous AI agents that go beyond simple Q&A. Our agents reason, plan, and execute multi-step workflows while you retain full code ownership and infrastructure control.
The entire platform runs on your infrastructure with zero external network dependencies. No calls to ibl.ai servers, no cloud telemetry, no external model APIs required. Suitable for the most sensitive research and clinical environments.
We collect nothing. No usage analytics, no prompt logging, no model inference data is transmitted externally. Your compound data, trial data, and patient-adjacent information never leave your environment.
Every agent action, user interaction, content access, and system event is logged with immutable timestamps and user attribution. Audit logs are exportable and structured for regulatory inspection and validation documentation.
Granular RBAC ensures clinical staff, regulatory teams, manufacturing, and external CRO partners each operate in isolated environments with appropriate data access. Multi-tenant architecture prevents cross-contamination of sensitive data.
Your security and validation teams receive the complete source code. Every authentication mechanism, data flow, and agent behavior can be independently audited, validated, and documented for IQ/OQ/PQ processes.
Platform architecture supports 21 CFR Part 11 electronic signature requirements. Training completions, agent-generated documents, and approval workflows can be configured with compliant e-signature controls.
Receiving full source code means your validation team can execute IQ, OQ, and PQ protocols against the actual codebase — not a vendor's black box. Required for GxP-regulated systems and FDA-facing applications.
Need to integrate with your CTMS, LIMS, or proprietary data warehouse? Extend an agent's workflow? Adjust a compliance rule? You own the code — modify it without filing a change request with a vendor.
On-premise, private cloud, air-gapped data center, or a hybrid architecture. The platform runs wherever your data governance and regulatory requirements dictate — not wherever the vendor's SaaS infrastructure is located.
Vendor risk is real in pharma. If ibl.ai ceased to exist tomorrow, your platform keeps running. No license server. No API key expiration. No forced migration. Your validated system remains stable.
Your compound libraries, clinical protocols, and regulatory strategies never touch shared infrastructure. Source code ownership combined with air-gapped deployment means your most valuable IP stays entirely within your control.
We deliver the complete ibl.ai source code to your team and support deployment on your target infrastructure — on-premise, private cloud, or air-gapped. We configure your model connections, authentication, RBAC, and audit logging. Your environment, your control from day one.
We work alongside your regulatory, clinical, and IT teams to configure agents for your specific workflows — regulatory document pipelines, clinical trial monitoring, GxP training compliance, or pharmacovigilance. We integrate with your CTMS, LIMS, EDC, and document management systems via MCP and APIs.
We support your validation team through IQ/OQ/PQ documentation and go-live. Once validated, your team operates the platform independently. No ongoing ibl.ai dependency. No per-seat licensing. No vendor access required to keep the system running.
Autonomous agents drafting, cross-referencing, and reviewing regulatory documents reduce submission preparation cycles from weeks to days, directly compressing time-to-approval timelines.
Automated training assignment, escalation, and record-keeping driven by compliance agents eliminates manual tracking gaps and sustains near-perfect compliance rates across sites and roles.
Continuous autonomous monitoring and automated CAPA initiation reduces the time from deviation detection to escalation from days to minutes, reducing trial risk and potential FDA findings.
Immutable audit trails, automated training records, and agent action logs mean inspection-ready documentation is always current — eliminating the manual scramble before regulatory audits.
Autonomous literature and data agents compress multi-day manual review cycles to hours, accelerating early-stage discovery and competitive intelligence workflows without adding headcount.
Governs electronic records and electronic signatures in FDA-regulated environments. Requires audit trails, access controls, and system validation for any computerized system used in regulated activities.
ibl.ai delivers full source code enabling independent system validation (IQ/OQ/PQ). Every agent action and user interaction is logged with immutable, timestamped audit records. RBAC and configurable e-signature workflows support Part 11 compliance. Air-gapped deployment ensures data residency requirements are met.
Good Practice regulations governing manufacturing, clinical, and laboratory environments. Require documented procedures, training records, deviation management, and data integrity across all regulated activities.
Autonomous agents enforce SOP-driven workflows, automate training assignment and record-keeping, and generate CAPA documentation. The platform's complete audit trail and source code auditability support GxP data integrity requirements across manufacturing, clinical, and laboratory contexts.
European equivalent to 21 CFR Part 11, governing computerised systems used in GxP environments. Requires supplier assessment, validation, data integrity, and audit trail capabilities.
Full source code delivery enables thorough supplier assessment and independent validation. Audit trails, access controls, and air-gapped deployment architecture directly address Annex 11 requirements for data integrity and system security in EU-regulated operations.
For pharmaceutical organizations handling patient-adjacent data from clinical trials, pharmacovigilance, or patient support programs, HIPAA governs the handling of protected health information.
Air-gapped deployment with zero telemetry ensures PHI never leaves your controlled environment. Role-based access controls, multi-tenant isolation, and complete audit logging support HIPAA administrative, physical, and technical safeguard requirements.
See how ibl.ai deploys autonomous AI agents you own and control — on your infrastructure, integrated with your systems.