by Kamile Gruduls | Aug 13, 2021 | Regulatory Affairs
Affiliate-Based Outsourcing (ABO) model for regulatory affairs works as a replacement or an extension of the company’s internal local regulatory resources, which often do not fully fulfil the needs for the effective organization, flexible resources, business...
by Nick | Aug 12, 2021 | EAEU, 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...
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...
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...
by Kamile Gruduls | Jul 5, 2021 | Regulatory Affairs, Webinar
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...
by Kamile Gruduls | Jun 21, 2021 | Regulatory Affairs
The Centralized Procedure in the GCC Region describes the possibility to register pharmaceutical products throughout the region. The Cooperation Council for the Arab States of the Gulf, abbreviated as “GCC” for “Gulf Cooperation Council”, came...
