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Drug Registration in the Eurasian Economic Union (EAEU)

by Nick | Aug 12, 2021 | Regulatory Affairs

If you are interested in marketing your medicinal product in the fast-growing pharmaceutical market of the Eurasian Economic Union (EAEU) and if you want to how to apply for market authorization in the EAEU, this blog post is for you. The first part of this article...

Marketing Authorization Renewal in the MENA Region

by Kamile Gruduls | Jul 30, 2021 | Regulatory Affairs

Regulatory Authorities across the MENA region indicate a specific validity period for the Marketing Authorization Approval certificate of pharmaceutical products that ranges between four to five years in most countries. The purpose behind this license validity period...

How to register a Medical Device in the EAEU

by Kamile Gruduls | Jul 9, 2021 | Medical Devices, Regulatory Affairs

Since the establishment of the Eurasian Economic Union in 2015, a significant change is quickly coming into life: a new regional registration system for medical devices is coming into effect from the start of 2022. As most registrations are completed through national...

How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?

by Kamile Gruduls | Jul 5, 2021 | Regulatory Affairs

Webinar: How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs? Affiliate-Based Outsourcing (ABO) Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources, which are often insufficient...

Setting Up A Pharmacovigilance System

by Nick | Jul 1, 2021 | Pharmacovigilance

Setting Up a Pharmacovigilance System from Scratch In the EU/EEA, US, and other major pharmaceutical markets, you need a sound plan for post-market surveillance for your medicinal product’s Market Authorization Application (MAA). A robust pharmacovigilance (PV)...

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Drug Registration in the Eurasian Economic Union (EAEU)

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Setting Up A Pharmacovigilance System

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Drug Registration in the Eurasian Economic Union (EAEU)

Marketing Authorization Renewal in the MENA Region

How to register a Medical Device in the EAEU

How to prepare for Affiliate-Based Outsourcing for Regulatory Affairs?

Setting Up A Pharmacovigilance System

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