We provide a 360º support for your landing in Europe
Internal Audit (gap analysis) and CAPA plan.
Quality Management System update according to EUGMP requirements.
Quality Risk Management, Validation Management, Cross-contamination management. High potency actives management. Suppliers’ audits. Technology transfer support. CMO agreements.
European QP and batch release agreements. European distribution GDP compliant agreements. Mockup inspections
Due-diligence of the dossier
Toxicology reports (ERA, nitrosamines, elemental impurities, mutagenic impurities)
Packaging materials design (including braille)
Labelling readability reports
High Quality National Translations in different EU languages
Dossier compilation (eCTD)Products registration in European agencies.
Pharmacovigilance System development and implementation
Safety reports (PSUR, DSUR, RMP, ACO, Signal Detection)Local QPPV & EU-QPPV
VIGILAZIERTA (Expert Database)
What possible ways has a company based outside the UE to land in Europe?
1. Do you want to manufacture for Europe?
Become a manufacturer for a local MAH.
As a CMO, a company based outside the UE can manufacture for a european MAH, according to the MA and the technical agreement.
2. Do you want to register your products in Europe?
Become a european MAH and hire a european CMO to manufacture your products.
Register your products in one or more European countries and find a local manufacturer .
3. Do you want to register and manufacture your own products for Europe?
Become a european MAH and manufacture your own products
Register your products in one or more European countries and manufacture your own products outside the EU.
Azierta can guide you and accompany you through all the process, providing expert support in every step of the way.