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What possible ways has a pharma company to land in Europe?

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)


Expert reports


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.

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 2,000 clients

9 year experience

10 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

DO YOU HAVE ANY DOUBTS?

We help you in everything you need. Contact us by filling out the form or book an appointment for a video call with one of our experts.

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