Regulatory Affairs

Waving Farewell to 2020 and Looking Forward to 2021

Waving Farewell to 2020 and Looking Forward to 2021

For everyone, 2020 has been a year of challenge and change. A once in a generation pandemic has meant rapidly altering the way we work and live our lives. Scott McGregor, Managing Director, reflects on our year and looks at…
Clinical Trials News and Regulations

Clinical Trials News and Regulations

As we reach the end of 2020, we release our final Industry Update of the year, compiled by Christina Hägglund, QA Manager, S-cubed Ltd. This quarter, we cover the latest COVID-19 Guidance and BREXIT news. You can download a pdf…
MHRA Post-Transition Period Information

MHRA Post-Transition Period Information

Clinical Trial Authorisations (CTA) - December 2020 Our Regulatory Affairs Team focus on the important information you need, as we approach the end of the BREXIT transition period. How will Brexit impact my clinical trial? MHRA has published several updates…
MHRA Submissions – The UK submissions portal from 01 January 2021

MHRA Submissions – The UK submissions portal from 01 January 2021

Following the end of the Brexit transition period in January, submissions relating to Clinical Trial Authorisations and Marketing Authorisations in the UK will need to be submitted via MHRA Submissions Portal, not CESP. MHRA Submissions First Step The first step…
Clinical Trials News from around the Globe

Clinical Trials News from around the Globe

With COVID-19 dominating clinical trials news, our latest industry update includes coverage of the key guidance documents issued by the regulators and much more. Compiled by Christina Hägglund, QA Manager, S-cubed Ltd. You can download the pdf of this update…