by Nick | Apr 1, 2021 | Regulatory Affairs
In a highly evolving regional pricing environment, Saudi Arabia (KSA) is no exception. The Saudi Food and Drug Authority (SFDA) has been periodically reviewing its pricing mechanisms and criteria so that the country becomes a regional reference for the prices of...
by Nick | Mar 25, 2021 | Regulatory Affairs
The interest of pharmaceutical companies in expanding business across CIS region has been constantly growing. For the same reason, Biomapas has expanded presence and now covers the whole CIS region, providing core services: clinical research, regulatory affairs,...
by Kamile Gruduls | Mar 23, 2021 | EAEU, Regulatory Affairs, Webinar
Webinar: Regulatory Strategy in the EAEU and Rest of CIS Countries Regulatory strategy in EAEU and CIS regions differ from other regions as market access to these countries can be a real challenge due to various local regulations. However, it is only a matter of...
by Nick | Mar 22, 2021 | Regulatory Affairs
Do we truly know how to ensure a well-written IND or IMPD Quality (CMC) part? Consistent and clear technical language? How to effectively manage the writing process? Biomapas can help you answer these questions and to set up the initial IND/IMPD required to start...
by Kamile Gruduls | Mar 20, 2021 | Regulatory Affairs, Webinar
Webinar: Effective IMPD Writing. The Quality Part Effective IMPD writing, including the quality part is a vital document that contains information about an investigational medicinal product and it is an essential part of the Clinical Trial Application (CTA), which is...
by Kamile Gruduls | Mar 17, 2021 | Regulatory Affairs, Webinar
Webinar: Successful Medical Device Registration in Russia. The Essentials The current national system for Medical Device registration in Russia was created from scratch and entered into force in 2013. Most experts agree that this system is complex and puzzling – some...
