Here are 5 things that you need to know about the FDA’s transition from paper based DMF’s to eCTD submissions:
1) All master files and documents submitted to existing master files must be submitted in eCTD. 2) What is a master file? The FDA considers a master file to be any of the following:NDA | New Drug Application |
ANDA | Abbreviated New Drug Application |
BLA | Biologics Licence Application |
IND | Investigation New Drug Application |
DMF | Drug Master File |
BPF | New Biological Product Files |
What Can You Do?
We can help you if you have not had the capacity or the time to transfer your paper-based dossiers to an electronic format. We are happy to help with an eCTD or DMF related query that you might have. Our publishing team is currently assisting a number of companies on FDA DMF related issues. Contact us on 00353 52 61 76706, email us: info@acornregulatory.com or simply fill in your details below and we will get back to you. [ninja_form id=1]Further Reading
eCTD & Publishing Services
Many companies choose to outsource all of their eCTD & Electronic Publishing needs to our team, while others seek our assistance on a project by project basis. Our expert team, headed by Eileen Ryan, has extensive experience of working on behalf of clients and managing their submissions to authorities around the world. The publishing sector is experiencing significant change at present with, among other issues, the change to mandatory eCTD. Our team can assist you in every aspect of your publishing needs. Read more about our services here.Outsourced eCTD Publishing Services: An Overview
More countries are implementing eCTD. As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services. We typically encounter three scenarios:- Companies that maintain control of electronic publishing at the corporate and head office level
- Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
- Companies that have outsourced eCTD entirely