Regulatory Affairs Archives

Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

by Nick | Jun 9, 2021 | Medical Devices, Regulatory Affairs

Webinar: Medical Device Registration in the Eurasian Economic Union (EAEU) The webinar on Medical Device Registration in the Eurasian Economic Union (EAEU) reviews the practical aspects of the approval procedure. We will discuss the various stages of the registration...

Affiliate Based Outsourcing for Regulatory Affairs

by Nick | May 25, 2021 | Regulatory Affairs

Webinar: Affiliate Based Outsourcing for Regulatory Affairs Affiliate based Outsourcing Model for Regulatory Affairs works as a replacement or an extension of the company’s internal and local RA resources. Many challenges come up from managing your RA activities as...

Company Registration Requirements in MENA: a Prerequisite for Product Registration

by Kamile Gruduls | May 12, 2021 | Regulatory Affairs

Company registration is part of the common regulatory requirements in several Middle Eastern and North African (MENA) countries. Nevertheless, it can be easily overlooked in preparation for drug filing and the overall regulatory picture.  MENA countries are accepting...

Biosimilars in the MENA Region: Regulatory Landscape

by Kamile Gruduls | Apr 27, 2021 | Regulatory Affairs

Regulatory affairs for biosimilars in Middle East North Africa (MENA) region are evolving as existing guidelines and regulatory frameworks are being updated. Since European Medicines Agency (EMA) introduced a legal pathway for biosimilars approval in 2004, several...

Successful Medical Device Registration in EAEU: New Legislation (Part 1)

by Nick | Apr 2, 2021 | Medical Devices, Regulatory Affairs

Webinar: Successful Medical Device Registration in EAEU: New Legislation (Part 1) The webinar discusses and explains the basic, essential, and theoretical matters of the EAEU system, outlines the new approach to the quality, safety, and efficacy assessments, and...

Saudi FDA’s New Pricing Guidelines and Impact on the Region

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...

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Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

Affiliate Based Outsourcing for Regulatory Affairs

Company Registration Requirements in MENA: a Prerequisite for Product Registration

Biosimilars in the MENA Region: Regulatory Landscape

Successful Medical Device Registration in EAEU: New Legislation (Part 1)

Saudi FDA’s New Pricing Guidelines and Impact on the Region

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Medical Device Registration in the Eurasian Economic Union (EAEU)(Part 2)

Affiliate Based Outsourcing for Regulatory Affairs

Company Registration Requirements in MENA: a Prerequisite for Product Registration

Biosimilars in the MENA Region: Regulatory Landscape

Successful Medical Device Registration in EAEU: New Legislation (Part 1)

Saudi FDA’s New Pricing Guidelines and Impact on the Region

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