News

With an approaching deadline of 1 January 2019, Health Canada is requesting industry input on establishing mandatory requirements for submitting drug master files (DMFs) using the electronic common ...
The original deadline for submitting Type III DMFs in eCTD format was May 5, 2017; however, that deadline was extended for an additional 12 months and subsequently pushed back again to May 5, 2020 ...
The DRAC team has been working to train themselves on how to prepare, publish, and view submissions in an electronic format since eCTD became operational.
Health Canada has proposed requiring all new Canadian Drug Master Files (DMF) to be submitted in Electronic Common Technical Document (eCTD) format effective January 1, 2019. The deadline for ...
Akron Biotechnology submits eCTD Drug Master Files with the FDA for its Recombinant Human Interleukin-7, Interleukin-15, and Interleukin-21.
Reed Tech eCTD publishing services offer a comprehensive solution for compiling, formatting and submitting regulatory submissions in electronic, compliant format.
Robust data is available for 25+ product and regulatory-related filters based on eCTD structure, including 6K+ source documents and over 2K links to Cortellis Regulatory Intelligence, providing ...
Akron Biotechnology submits eCTD Drug Master Files with the FDA for its Recombinant Human Interleukin-7, Interleukin-15, and Interleukin-21.