From molecule to market, faster.
Compress trials, accelerate submissions and unblock MLR — on a GxP-aligned platform with full validation and audit.
Where current AI stacks break.
Patent cliff is real
Top-20 pharma faces ~$200B in revenue at risk through 2030.
MLR is the bottleneck
Medical-Legal-Regulatory review is choking commercial AI velocity and HCP engagement.
Submission complexity
FDA, EMA and PMDA expect ever-richer eCTDs.
GxP validation overhead
Weekend pilots can't graduate to GxP environments without traceable, validated workflows.
Data sprawl
Trial, RWD, omics, CRM and IRT data live in incompatible systems and across CRO partners.
Patient-data sovereignty
PHI and trial data cross borders, partners and contracts.
Ship in weeks, not years.
Pre-built, evaluated and governed — on Synaptix Cloud or on-prem.
Literature & Competitive Intelligence Agent
Continuously monitors PubMed, conferences, ClinicalTrials.gov and patents.
Regulatory Authoring Agent
Drafts CTD modules, briefing books, IND/NDA sections and labeling updates with sentence-level source traceability.
Medical Affairs / MSL Copilot
Prepares HCP-ready content, answers off-label inquiries with on-policy disclaimers and logs interactions to Veeva.
MLR Pre-Review Agent
Pre-screens commercial content against claims libraries and references.
Clinical Operations Agent
Site selection, monitoring summaries, protocol deviation triage and CRO oversight across portfolios.
Pharmacovigilance Triage
Case intake, MedDRA / WHO-DD coding draft, seriousness assessment and prioritization for safety physicians.
Real-World Evidence Agent
Cohort discovery, feasibility and signal detection across RWD, EHR and claims data sources.
Market Access & HEOR Agent
Drafts payer dossiers, AMCP submissions and budget-impact narratives with traceable evidence.
Built for regulated workloads
Native systems integration
Resources for pharma & life sciences teams
MLR review accelerated 4× with multilingual GLM-5 agents
PII-redacted gateway and 21 CFR Part 11-ready control plane.
GxP, 21 CFR Part 11 and GDPR posture
What auditors get on day one.
EU AI Act readiness
Mapping high-risk pharma workloads to the regulation.
Ready to operationalize your agents?
Talk to our team about a pilot on Synaptix Cloud or on-prem.