Pharma operations systems

Validated software.
Built around your process.

Custom systems for regulatory, pharmacovigilance and quality operations. With AI where it helps.

ValidatedGAMP 5 · CSA

AI Assistantbuilt into the system

Source codeowned by the client

4operational areas covered

3product types: medicines, devices, cosmetics

5phases, each with its deliverable

0licence or per-user fees

Two areas. One domain expertise.

Validated systems for RIM, pharmacovigilance, quality and suppliers.

AI built into our software, AI consulting and ELENTIA pilot projects.

Registrations, variations, renewals, submissions.

ICSRs, reporting timelines, PSMF, SDEAs.

GxP documents, change control, deviations and CAPA.

Quality agreements, contracts, audits, budgets.

The key question

Not which regulatory suite to buy, but which capabilities the company needs, and which of them justify a dedicated system.

Available on request.