FDA and GxP-aware compliance infrastructure for pharmaceutical and biotech agent operations.
Shulam combines regulatory-grade audit trails, vendor qualification screening, research budget governance, and clinical trial payment management into one platform built for the most regulated industry in the world.
Each agent settlement produces a cryptographic receipt containing the OFAC screening result, counterparty details, fee calculation, settlement confirmation, and on-chain proof. Receipts are hash-chained — tamper with one and auditors can detect it instantly. Meets 21 CFR Part 11 and EU Annex 11 expectations for electronic records.
Compliance receipt — Clinical trial procurement
Every vendor, CRO, and supplier address your agents transact with is screened against OFAC SDN lists in under 200ms. New vendor onboarding includes automatic screening. Screening receipts serve as vendor qualification documentation. No more manual checks with 48-hour turnaround.
Vendor screening — Q1 2026
Define spending policies by study, therapeutic area, or business unit. Category restrictions ensure study agents only purchase within approved budget lines. Daily, weekly, and monthly caps align with study allocations. PIs manage their own agents; finance sees the institutional rollup.
Study budget policies
Clinical trial site payments, investigator disbursements, and CRO milestones all flow through Shulam with automatic OFAC screening and compliance receipts. Enterprise tier includes dedicated infrastructure, SOC 2 reporting, SSO/SAML integration, and white-label deployment for CRO clients.
Enterprise compliance features
Hash-chained, tamper-evident receipts with attribution, timestamps, and 7-year retention. ALCOA+ principles built in.
Every supplier address screened before payment. Screening receipts serve as qualification documentation.
Spending policies tied to study budgets. Category restrictions. Daily and monthly caps. Violations held, not settled.
Daily summaries, weekly risk digests, monthly packages. Export in CSV, JSON, PDF. Ready for FDA inspection.
Automated site disbursements with OFAC screening and compliance receipts. Same-day processing.
Enterprise tier: your brand, your dashboards. Dedicated infrastructure, custom SLA, SOC 2 reporting.
“Our FDA inspection prep used to take three weeks of manual documentation assembly. With Shulam, every agent transaction already has a hash-chained compliance receipt. We exported 8,900 receipts for the inspector in under a minute. The inspector called our audit trail exemplary.”
Free to start. Enterprise tier for regulated environments. ALCOA+ audit trails included.
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