MAX's AI AgentBuilt for Regulated Industries
MAX is a collection of specialized AI agents orchestrated to solve complex business workflows.
The MAX AI Agent gives pharma, life sciences, healthcare and other regulated enterprises controlled intelligence for audit-ready compliance workflows, regulatory and document intelligence, SOP impact analysis, CAPA management and evidence-based decisions.
Get Started in 48 HoursIntelligence you can govern
A governed framework coordinates AI agents within your approved business context. Industry knowledge and enterprise controls define how MAX operates. No irrelevant sources.
A confidence model validates every output against thresholds you set and provides clear rationale when evidence is insufficient. No unsupported answers.
Private by default. Your documents and data remain within your governed enterprise environment. Your data stays under your control.
Auditable answers with measurable confidence. MAX evaluates every response for completeness, accuracy and relevance against thresholds you define. Teams can inspect the evidence, refine the approach and retain control. Know why every answer can be trusted.
Answers grounded in approved knowledge. Control the context MAX can use, from governed documents and SOPs to regulatory requirements and enterprise policies. Your knowledge defines the response.
Confidence engineered into every output. A proprietary validation model keeps responses grounded, explainable and ready for human review. Move from evidence to decision with confidence.
MAX accelerates regulated work without compromising control
When ICH E6(R3) was issued, a pharmaceutical client needed to assess and apply the regulation across its entire SOP inventory — work that typically requires 120–140 days of regulatory trigger analysis, document categorization, gap assessment, redlining and approval.
Using MAX, GenasysAI reduced the cycle to 10 days. The MAX AI Agent automated SOP classification, regulatory impact analysis and traceability mapping, completed 80% of the gap analysis and applied tracked changes directly to controlled documents. Consulting effort fell by 60–70%, experts shifted from manual review to focused oversight, and the client met its enforcement deadline with complete audit trails.
Put MAX to work
Configure the MAX AI Agent around your regulated processes, approved knowledge and existing systems. Add AI workflow automation without replacing established controls.
Compliance Inspector
Assess controlled documents against regulatory requirements. Generate cited gap reports and tracked revisions for expert review.
Compliance Inspector
Regulatory Use Cases
- Assess SOPs against applicable regulations and GxP requirements
- Check INDs, NDAs, MAAs and CTD modules for completeness before submission
Eliminate:
- Weeks of manual regulatory review
- Compliance gaps discovered during audits
- Inconsistent reviewer decisions
Content Evaluator
Evaluate protocols and procedures against external evidence. Answer defined questions with cited, review-ready recommendations.
Content Evaluator
Clinical Use Cases
- Evaluate trial protocols against current evidence and regulatory expectations
- Test regulatory strategies against approval pathways and agency precedent
- Assess CRO capabilities against new trials and bid requirements
Eliminate:
- Decisions made without complete evidence
- Weeks of manual evidence synthesis
- Unstructured, unsupported conclusions
Content Aligner
Compare critical documents across the enterprise to identify gaps, duplication and material process conflicts.
Content Aligner
Document Use Cases
- Identify conflicts across sponsor, CRO and internal SOPs
- Map local, global and affiliate SOPs to measure procedural alignment
Eliminate:
- Manual line-by-line comparison
- Hidden process contradictions
- Gaps between sponsor and CRO documents
Oversight Manager
Compare planned and executed clinical activities to surface deviations, risks and oversight priorities earlier.
Oversight Manager
Oversight Use Cases
- Flag protocol deviations against planned site and sponsor activities
- Maintain current audit trails aligned with ICH GCP E6(R3)
Eliminate:
- Late-stage deviation discovery
- Manual plan-versus-actual reconciliation
- Reactive sponsor oversight
Deploy MAX's AI Agent with control from day one
Start with governed AI.
MAX begins with established context controls and confidence validation built for regulated enterprise work.
Connect approved knowledge.
Connect documents, records and data to configure MAX around your business context and governance requirements.
Put MAX into operation.
Begin using configured MAX capabilities within 48 hours, with enterprise controls already in place.
See governed AI
at enterprise scale.
See how the MAX AI Agent applies controlled intelligence to your regulated workflows — configured for your enterprise and ready within 48 hours.