DeepC Enterprise: Built for the regulated enterprise
Sixteen specialist agents grounded in FDA, EMA, ICH, USP, and your own SOPs. Every claim cited to its primary record. Every action audit-logged.
Five layers. One co-scientist.
From the chat surface your scientists use down to the compute running inference, DeepC works as one auditable system, every layer designed to leave a verifiable trail.
- Chat workspaceMission ControlAudit · Roles · Provenance · 7-year retention
- Sixteen specialist agentsFor FormulationICH Q8(R2) / CTD §3.2.P.2
- Reality Anchor reasoningFor Safety AssessmentERA · E&L · Nitrosamines · OEL · PDE
- Knowledge graph & citationsFor Regulatory Filingsubmission-ready PDFs
- Foundational computeFor Custom Agentsfine-tune on your SOPs
Built for what an R&D org actually does.
What your scientists actually ship.
Submission-ready dossiers, ranked safety evidence, candidate formulations, pulled straight out of DeepC, anchored to citable sources, ready for your QA and ready for your regulator.
Lacosamide 10 mg/mL solution for infusion
- Ks 1
ECHA IUCLID Dossier 100.005.235
NOAEL (rat, 90-day oral) · ECHA REACH
GLP-compliant 90-day oral gavage study in Sprague-Dawley rats (5/sex/dose) at 0, 50, 150, 500 mg/kg/day. NOAEL of 150 mg/kg/day established; LOAEL of 500 mg/kg/day driven by hepatic centrilobular hypertrophy.
- Ks 2
EFSA peer-reviewed re-evaluation (2023)
NOAEL (rat, 90-day oral) · EFSA
Authoritative re-evaluation citing the underlying ECHA dossier. Concurs with NOAEL of 150 mg/kg/day for the same critical effect.
- Ks 2
Mortelmans et al. PMID 3781131
NOAEL (rat, 90-day oral) · PubMed
Peer-reviewed primary publication of the same 90-day oral toxicity study program. Methodology documented in detail; conclusions match the ECHA dossier.
- Ks 3
NTP TR-403 (secondary citation, trade publication 2019)
NOAEL (rat, 90-day oral) · Industry whitepaper
Reports a NOAEL of 50 mg/kg/day citing NTP TR-403. The cited NTP study uses a different strain (F344, not Sprague-Dawley) and a different route (drinking water, not gavage).
Rejected by Reality Anchor: Strain and route mismatch; superseded by Ks 1 ECHA dossier.
MR Matrix (HPMC K100M)
| Excipient | Function | % w/w |
|---|---|---|
| Active | API | 35 |
| HPMC K100M | Hydrophilic matrix former | 30 |
| Lactose monohydrate | Filler | 25 |
| Microcrystalline cellulose | Filler / binder | 8.5 |
| Magnesium stearate | Lubricant | 1 |
| Colloidal silicon dioxide | Glidant | 0.5 |
HPMC K100M selected as the primary release-control matrix at 30% w/w; concentration sits within IID precedent for oral MR products on Mirapex ER (NDA 022030). Lactose monohydrate and MCC chosen for direct-compression compatibility and to stabilise the API in a low-water-activity matrix.
Compliance & Governance
Every action you'd report in an audit, already logged. DeepC records every prompt, agent invocation, retrieval call, document upload, regulatory PDF export, and role change with a tamper-evident hash chain. Audit logs stream to your SIEM in real time and are retained for seven years to meet 21 CFR Part 11 and GxP requirements. Mission Control gives compliance teams scoped read-only access to the entire trace.
- 21 CFR Part 11 electronic records & signatures
- GxP-aligned SDLC and change control
- Klimisch reliability tiers on every cited toxicology study
- 7-year audit retention
- Tamper-evident log hash chain
Reliability & Scale
Built for production research workloads. The chat surface, the analytics sandbox, and the regulatory PDF compiler each run on independently autoscaled fleets. We target 99.9% uptime under SLA, with multi-region failover for organizations filing in multiple jurisdictions simultaneously.
- 99.9% uptime SLA target
- Multi-region failover
- Independent autoscaling for chat, sandbox, and PDF compile
- Capacity planning during regulatory crunch (PDUFA, MAA submission windows)
- Status page + dedicated Slack support channel
Mission control, as you'll actually use it.
These three views are lifted directly from the deployed enterprise admin console: what your admins and compliance officers see when they log in.
Overview
Month-to-date spend, seat usage, agent-call volume, top agents, and the live activity feed, the first thing your org admins see when they log in.
Audit Log
Every prompt, document export, role change, and signature recorded with category, actor, resource, and status. 21 CFR Part 11 retention. Filterable. GxP-tagged.
Users
Seat-scoped role assignment with passkey-first auth. Org Admins, Admins, Users, and Read-only auditors, all SCIM-provisionable from your IdP.
Book a demo.
Tell us what you are working on (molecule, indication, stage, open question).
A formulation lead will be in touch within a business day.