Recently, the FDA held a free webinar in its CDER Small Business and Industry Assistance (SBIA) Webinar Series on “OPDP ...

In early October, Phlexglobal was honored to welcome industry TMF professionals from over thirty pharmaceutical ...

As part of our continuous global regulatory updates and in case it did not catch your attention, please be reminded on ...

The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic ...

As part of the DIA RSIDM conference in Bethesda, ML in February 2019, the following comprehensive list summarizes our ...

eCTD has been around for nearly 20 years and we’ve seen how it has transformed the regulatory submission landscape. The ...

While the EMA is currently busy moving to the Netherlands and while the IDMP project currently seems to go slow, there ...