Pharma & Life Sciences
Sovereign AI for drug development.
Regulatory document processing, clinical data extraction, and pharmacovigilance that runs entirely within your validated environment. No patient data ever leaves your walls.
01 — Regulatory Submissions
Accelerate regulatory review.
Automate document preparation, cross-referencing, and quality checks for FDA, EMA, and global regulatory submissions.
- Automated CTD/eCTD document assembly and validation
- Cross-reference checking across submission modules
- Legacy document digitization and indexing
- Real-time compliance gap analysis
Reduce submission preparation time by 60%. Catch compliance gaps before they become rejection letters.
Results
60%
Faster prep
Zero
Data leakage
100%
Audit trail
02 — Clinical Trial Data
From documents to decisions.
Extract and structure clinical trial data from diverse sources while maintaining complete chain of custody.
- Protocol and SAP document extraction
- Adverse event report processing and coding
- Lab report normalization and trend analysis
- Cross-study data harmonization
Clinical teams spend time on analysis, not data wrangling. Complete data provenance for FDA inquiry.
Results
80%
Time saved
99.5%
Extraction accuracy
Full
Provenance
03 — Pharmacovigilance
Safety signals. Zero delay.
Process safety reports at scale while maintaining the human oversight regulators require.
- ICSR processing and MedDRA coding
- Literature screening and case identification
- Signal detection across global safety databases
- Automated PBRER/PSUR generation
Meet reporting deadlines consistently. Never miss a safety signal buried in unstructured data.
Compliance Built In
Validated workflows that satisfy the most rigorous regulatory inspection.
Why Synapze for Life Sciences
Built for validated environments.
Pharma companies can't risk patient data or regulatory standing on cloud AI. Synapze was built from day one for air-gapped, GxP-validated deployment.
21 CFR Part 11 compliant by architecture
Air-gapped operation for sensitive trial data
Models trained on your proprietary documents
No patient data ever leaves your environment
Complete audit trail for regulatory inspection
GxP-validated deployment option
Start with a one-model pilot.
A 30-minute discovery call, a no-obligation ROI assessment, then a pilot on a single process. Prove it works before you commit.