How effective is your EMVO Alert Management Strategy?

How effective is your EMVO Alert Management Strategy?

Sep 16, 2021 | Serialization

Introduction To avoid falsified medicines reaching the supply chain, European Medicines Verification Organization (EMVO) has designed a robust alerting functionality to track any potential falsified medicines that reach the supply chain. The EU FMD framework was...
Medical Devices EU regulations for MDR – Part 1

Medical Devices EU regulations for MDR – Part 1

Sep 3, 2021 | Serialization

Introduction The EU MDR is a new set of regulations that came into effect on 26th May 2021, following a 4-year transition period after being adopted in May 2017. It aims to improve the safety and performance of the device throughout the lifecycle by tightening up the...
SFDA Dossier requirements

SFDA Dossier requirements

Aug 27, 2021 | Serialization

  The SFDA Dossier requirements differ for each application. What is important to note is that the CTD provides a format for an MAA (Marketing Authorization Applcication) Also to be noted is that regional and national requirements may affect the content of a...