Regulations & Guidance feature in our Q1 Industry Update from Christina Hägglund, QA Manager S-cubed Ltd. You can download a pdf of this update here and sign up to receive our updates via email here. COVID-19 Guidance & Information Europe…
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…
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…
EMA Publishes a New Question and Answer Document for Marketing Authorisation Holders on the CHMP Opinion for the Article 5(3) referral on Nitrosamine Impurities in Human Medicinal Products (EMA/409815/2020) The European Medicines Agency (EMA) have published a new ‘question and…
Our Regulatory Affairs team have produced this article with the aim of summarising the key elements of the EMA Reflection Paper and the GMP-related responsibilities that apply to Marketing Authorisation Holders. The article also aims to assist our clients in…
