DeepCeutix provides AI‑driven knowledge agents that support pharmaceutical teams across formulation, CMC, and regulatory stages, from preclinical development to commercial launch. By ingesting regulatory corpora, private data, and physics‑based models, the platform offers evidence‑backed answers for tasks such as IV‑to‑oral conversion, solid dispersion design, and patent landscape analysis, while maintaining compliance with HIPAA, GDPR, and 21 CFR Part 11.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical teams face lengthy, costly formulation and CMC development cycles that are hampered by fragmented data sources, manual expert work, and regulatory compliance burdens, slowing the path from lead compound to market.
Solution
DeepCeutix offers an AI‑driven platform that acts as a virtual co‑scientist, integrating private project data, regulatory corpora, and physics‑based calculations to generate formulation designs, CMC strategies, safety dossiers, and IP analyses. The system’s specialist agents retrieve and cite authoritative sources, ensuring every claim is traceable to regulatory texts or peer‑reviewed literature. By automating formulation screening, optimization, and regulatory documentation, DeepCeutix reduces development timelines from months to minutes while maintaining audit‑ready provenance and compliance with FDA, EMA, ICH, and GxP standards. The platform also provides secure, compliant data handling (HIPAA, GDPR, 21 CFR Part 11) to protect proprietary information.
Target Audience
Primary customers are formulation scientists, CMC teams, and regulatory affairs groups within large pharmaceutical companies developing small‑molecule, biologic, and gene‑therapy products.
Features
- AI agents for formulation design, optimization, and solid‑dispersion screening across oral, IV, and advanced modalities (e.g., high‑concentration mAbs, LNP‑mRNA, AAV gene therapy)
- Integrated IP clearance and patent drafting tools that map freedom‑to‑operate and generate USPTO‑formatted drafts
- Automated safety dossier generation (extractables, leachables, nitrosamines, OEL, PDE) anchored to ICH and USP guidelines
- Knowledge graph and persistent memory to link project data, literature, and regulatory sources with multi‑source citation provenance
- Reality Anchor constraint layer that enforces thermodynamic and regulatory consistency, preventing AI hallucinations
- Enterprise‑grade audit log with tamper‑evident hash chain, 7‑year retention, and real‑time SIEM streaming for 21 CFR Part 11 compliance
- Role‑based project collaboration, secure file ingestion, and SCIM‑compatible identity management