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

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

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 ...

Australia is phasing out eCTD Specification version 3.0 on 30th June 2018. The Therapeutic Goods Administration (TGA) ...

eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format ...