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WEBINAR: Navigating API Change Management in Japan

Change Management

We recently held a webinar on the topic of change management in Japan. Teva api regulatory and change management experts, Marianna Kishinevsky and Rinat Bordman, discussed the change management landscape in Japan and how we, at Teva api, utilize our local, dedicated team in Japan to navigate the complex and frequent changes that require control […]

Did You Join Us for the Webinar Nitrosamines: A Moving Target? Here’s Your Recap!

Our recent webinar, Nitrosamines: A Moving Target was a deep-dive into the issue of Nitrosamines impurities and how you can stay on top of the various evaluation requirements to remain compliant. During the webinar, Diana Van Geenhoven, our head of global compliance, Lena Ben Moha-Lerman, Senior Director of Lifecycle Management within Teva api’s R&D team […]

GMP audits reports during COVID-19 times

Completing a Good Manufacturing Practices (GMP) audit report prior to 2020 was simple. Companies had many ways to get theirs done, and a large percentage opted for performing their own onsite audits at their suppliers’ facilities, and then putting together the report themselves. This year however, with travel so limited, this option is difficult if […]

Regulations in Brazil are Changing

API regulation affairs in Brazil

On April 1st, 2020, Brazil’s ANVISA published new landmark regulations referring to active pharmaceutical ingredients (APIs). This new set of rules consists of three separate guidelines for local pharmaceutical segment stakeholders, known as “RDCs”. These are RDC 359/2020, RDC 361/2020 and RDC 362/2020, and they represent a complete overhaul of the API regulatory landscape in […]