Pharmacovigilance
EU GVP-aligned operating model with Malta as EU PV HQ control hub and global safety execution coverage.
View serviceServices
Malta-based EU Pharmacovigilance & Regulatory Headquarters. Global lifecycle execution-not only EU submissions.
We support pre-market, clinical, post-market, and mature products across EU, UK, US, MENA, APAC, and LATAM with operational, quality, and regulatory delivery depth.
Regulatory Affairs
Global regulatory lifecycle execution-not only EU submissions-with cross-region harmonization and change control.
View serviceClinical Trials
GCP-aligned CRO-level operational support with documentation quality and inspection-readiness focus.
View serviceRegulatory Intelligence
Horizon scanning, impact briefs, and action plans that turn regulatory change into operational clarity.
View serviceMedical Devices
MDR/IVDR readiness plus global device lifecycle operations, PMS and vigilance execution support, and technical file discipline.
View serviceCosmetovigilance
Defensible undesirable effects workflows and safety documentation toolkits for cosmetic portfolios.
View serviceFood Supplements
Global supplement compliance execution with EU control baseline, claims and labeling support, and market-readiness packs.
View servicePV Quality Systems
SOP governance, templates, review cycles, and escalation controls for sustained audit readiness.
View serviceOperating Model
- 1. Discover
- 2. Scope
- 3. Build
- 4. Validate
- 5. Maintain