AX/V/08 · Healthcare & MedTech
Automation for healthcare and medtech.
Medtech / pharma / lab company does not need to manually check FDA, EMA and clinical trials daily. We build systems that monitor regulatory updates, aggregate clinical trial data and alert on competitor approvals — with audit trail required by compliance.
AX/01 — Typical problems
- 01Regulatory specialist checks FDA/EMA daily — 2-3h work, easy to miss an update
- 02Clinical trials in 8 languages + 12 platforms (CTIS, EU CT Register, ClinicalTrials.gov, local portals)
- 03Competitor approvals visible 3 days post-publication — first PR/legal reaction delayed
- 04Drug pricing data (reimbursement lists, NFZ refunded drug list) — chaos of quarterly updates
- 05Audit trail required for compliance — manual tracking impossible
AX/02 — What we build for them
- Regulatory monitoring (FDA + EMA + Health Canada + MHRA + local agencies) with change detection
- Clinical trial aggregation (CTIS, EU CT, ClinicalTrials.gov, JPRN) with normalized schema
- Competitor approval alerts (push within <2h of gov registry publication)
- Drug pricing intelligence (reimbursement lists, EU equivalents, ex-factory prices)
- Adverse event monitoring (EudraVigilance, FAERS — tracking by molecule/indication)
- Immutable audit trail (every data point with timestamp + source + hash chain)
AX/03 — Related projects
OPS-25-D3
11.6×
output
Multi-account content & outreach orchestration for a creator network
47 brand accounts, four platforms, one operator console. Scheduling, engagement, analytics and human-in-the-loop review built end-to-end.
OPS-26-H4
-84%
analyst review time
KYC adverse media screening automation for compliance
Hybrid browser automation + Claude agent. 40+ news sources, 11 languages, compliance-grade audit trail. KYC analyst review time dropped 84%.
AX/04 — Industry FAQ
01Are you GxP / 21 CFR Part 11 / Annex 11 compliant?
Architecture with digital signature, immutable log, role-based access, change control — compatible with Part 11 / Annex 11. Specific validation per client — requires IQ/OQ/PQ before go-live in a regulated environment.
02What about patient data?
We do NOT work with patient PHI/PII. Pipelines do public regulatory data + commercial data (drug prices, trials metadata, competitor info). Patient data → separate area requiring HIPAA/Annex 11 dedicated implementations.
03How fast are competitor approval alerts?
EMA publishes opinions after CHMP meetings — alerts typically within <1h of official publication. FDA Approval Letters — <2h. Local agencies (MHRA, AIFA) — <6h depending on portal.
04Do you exploit clinical trial data?
All monitored registries publish data publicly (registration obligation). We do not enter private trial data, sponsor IP, or investigator brochures.
05How much does it cost?
Mid-size pharma (local): setup €15-30k, retainer €2-5k/month. Multi-region pharma: €40-100k setup, €5-15k/month. MedTech startup with 1-2 products: setup €8-20k, retainer €1-3k/month.
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