🔬 AI Automation · Pharma & Life Sciences

Less paperwork. More breakthroughs.

GMP documentation, batch records and regulatory submissions cost your scientists hours per week. We automate the administrative layer — so your lab can focus on research.

50%

less documentation effort

95%+

GMP compliance rate

2× faster

submission preparation

Pain Points

What holds Pharma & Life Sciences companies back every day.

01

GMP documentation costs researcher time

SOPs, batch records, deviation reports — scientists document instead of research.

02

Regulatory submissions time-consuming

Swissmedic and EMA submissions require hundreds of pages of structured documentation.

03

Clinical data fragmented

Study data scattered across CROs, clinics and internal systems — consolidated manually.

04

Change control bureaucratic

Every process change requires impact assessment, approval workflow and implementation documentation.

Concrete Use Cases

AI automation for Pharma & Life Sciences.

01

SOP & Batch Record Automation

Generate SOPs from templates, version, forward for approval and archive after sign-off.

02

Deviation Management

Capture deviations, generate CAPA actions, assign responsible parties and track to closure.

03

Clinical Study Administration

Automate patient data routing, protocol tracking and safety reporting for clinical studies.

04

Change Control Workflow

Submit change requests, request impact assessments, obtain approvals and document implementation.

05

Regulatory Intelligence

Automatically monitor new guidelines from Swissmedic, EMA and FDA, summarise and distribute to Regulatory Affairs.

06

Supplier Qualification

Automatically request, check and archive supplier audits, certificates and qualification documents.

Compliance & Data Protection

All solutions are built GMP-, GCP- and Swissmedic-compliant. Full audit trails, electronic signatures (21 CFR Part 11 / Annex 11), encrypted data storage and validation documentation included.

FAQ

Frequently asked questions.

Are your solutions GMP-validatable?

Yes. We provide the necessary validation documentation (IQ, OQ, PQ). Formal GMP validation and QA approval remains with the pharmaceutical company.

Can you integrate with LIMS and electronic lab notebooks (ELN)?

Yes — provided an API or data export option is available. We have experience with most life sciences systems.

How is it ensured that no study data leaves the company?

We build exclusively on-premises or on your private cloud. No data sharing with third parties.

Which Swiss pharmaceutical companies benefit most?

CROs, CMOs, biotech startups and medium-sized pharma companies with high documentation volumes.

Get started

Automate Pharma & Life Sciences — risk-free.

Free Discovery Call: In 30 minutes we show you which processes can be automated immediately — and what that means in concrete terms.

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