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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.

FDA 21 CFR Part 11EMA Annex 11ICH GuidelinesGDPRHIPAAGxP

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

Results

60%

Faster prep

Zero

Data leakage

100%

Audit trail

Reduce submission preparation time by 60%. Catch compliance gaps before they become rejection letters.

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

Results

80%

Time saved

99.5%

Extraction accuracy

Full

Provenance

Clinical teams spend time on analysis, not data wrangling. Complete data provenance for FDA inquiry.

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

Compliance built in

ICH E2B(R3)EudraVigilanceFDA FAERSGxP

Meet reporting deadlines consistently. Never miss a safety signal buried in unstructured data.

Why Synapze for life sciences

Built for validated environments.

Pharma 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

Get started

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.

No GPU procurement · No core banking disruption · Live in 12 weeks