Biotech & Pharma

From hypothesis to filing, faster

Syntic AI Employees accelerate research, regulatory, and medical affairs — synthesizing literature, drafting submission sections, and keeping every claim traceable to its source.

8x
faster literature review on target validation
40%
of CSR sections first-drafted by Syntic on partner pilots
21 CFR
Part 11 controls supported

Where Syntic moves the molecule

Research synthesis

Triangulate literature, internal data, and trial readouts into evidence-graded memos.

Regulatory drafting

INDs, CSRs, briefing books — first drafts with citations and tracked rationale.

Trial operations

Protocol deviations, monitoring summaries, and site comms handled with auditability.

Connects to your data

Veeva, EDC systems, internal SharePoints, and licensed literature — wherever the source of truth lives.

Validated workflows

Versioned prompts, frozen models on request, and full review trails for GxP use.

Private deployment

VPC, on-prem, and BAA available; no training on your data.

How teams put it to work

01

Target validation

Synthesize 10,000+ papers into a ranked landscape your team can act on in days, not months.

02

Clinical study reports

Draft sections with linked citations and SDTM/ADaM-aware tables your medical writers refine.

03

Medical affairs

Field-medical briefing docs, KOL summaries, and competitive intelligence at the cadence the field needs.

04

Regulatory intelligence

Track guidance changes across FDA, EMA, PMDA and notify the right owners.

Capabilities

  • 21 CFR Part 11 supporting controls
  • GxP-aware audit logging
  • Customer data never used for training
  • Veeva, IQVIA, EDC integrations
  • Region-pinned residency (US, EU, JP)
  • Validation evidence package on request

Put AI Employees on your next program

We work with biotechs, top-20 pharma, and CROs. Pick a milestone — we'll scope a 60-day pilot to hit it.