Regulatory Affairs Archives

How does the Russian invasion impact the pharmaceutical industry?

by Nick | Mar 10, 2022 | Clinical Research, Pharmacovigilance, Regulatory Affairs

Like the rest of the world, the pharmaceutical and biotech industries are beginning to worry about their ability to continue operations. And, with good reason. Russia’s invasion of Ukraine affects millions of people, not just in this Eastern European nation but...

Smooth Switch to the EAEU Marketing Authorization for Medicinal Products

by Kamile Gruduls | Jan 6, 2022 | EAEU, Regulatory Affairs, Webinar

Webinar: Smooth Switch to the EAEU Marketing Authorization for Medicinal Products The webinar will highlight the practical tips and guide you through the crucial steps of marketing authorization upgrade to the Eurasian Economic Union (EAEU) one, ultimately leading you...

Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation

by Kamile Gruduls | Dec 20, 2021 | Medical Devices, Regulatory Affairs

There is an increased demand for Materiovigilance solutions in recent years as the usage of medical devices keeps growing. Current industry changes are already impacting future developments, and it is becoming more and more challenging to keep up with recent...

Download – ABO Whitepaper

by Nick | Oct 25, 2021 | Pharmacovigilance, Regulatory Affairs

Whitepaper Regulatory Affairs Outsourcing Affiliate-Based Outsourcing for Regulatory Affairs acts as an addition or replacement of your in-house local regulatory capabilities. However, it frequently falls short of meeting the requirements for effective organization,...

What is the Clinical Trials Regulation?

by Nick | Oct 14, 2021 | Clinical Research, Regulatory Affairs

The EU CTR is the new Regulation that govers all interventional clinical trials using human medicinal products. By implementing this Clinical Trials Regulation (CTR) early 2022, the European Commission hopes to establish a better environment for clinical trials in the...

Different Affiliate Based Outsourcing Models for Regulatory Affairs

by Kamile Gruduls | Oct 10, 2021 | Regulatory Affairs, Webinar

Webinar: Different Affiliate-Based Outsourcing Models for Regulatory Affairs Often questions arise about the Affiliate-Based Outsourcing (ABO) Models for Regulatory Affairs:1. How can it fit your specific needs?2. How can it adapt to your organization and setup?3....

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How does the Russian invasion impact the pharmaceutical industry?

Smooth Switch to the EAEU Marketing Authorization for Medicinal Products

Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation

Download – ABO Whitepaper

What is the Clinical Trials Regulation?

Different Affiliate Based Outsourcing Models for Regulatory Affairs

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How does the Russian invasion impact the pharmaceutical industry?

Smooth Switch to the EAEU Marketing Authorization for Medicinal Products

Finalization of the European Database on Medical Devices (Eudamed) Regulation Implementation

Download – ABO Whitepaper

What is the Clinical Trials Regulation?

Different Affiliate Based Outsourcing Models for Regulatory Affairs

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Regulatory Affairs

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Medical Information

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