The 3 Options for eCTD Publishing & Submission Services
The transition from paper-based submissions to the more costly eCTD system has caused many companies to reconsider how they undertake regulatory publishing. Acorn Regulatory was an industry leader in the early adoption of eCTD technology in 2014 and we have worked with hundreds of companies to manage their electronic submissions and to train their staff in eCTD technologies since then. This article looks at the three options open to companies when considering how to manage eCTD publishing & submission within their company.
1. In House: Companies that maintain control of submission at the corporate and head office level
Companies that maintain control of eCTD publishing at a corporate level can face challenges with streamlining processes and adjusting procedures for collecting the local national requirements needed for the eCTD submissions. This is a big adjustment from past processes where core dossier documentation could be filtered out to the local affiliates/partner and they would include the national local requirements to submit to the authorities without a need for further input from the corporate office. In addition, as final submissions are made at a national level, then gathering/coordinating the registered information of the MAs back to a corporate level to start eCTD lifecycle can be problematic.
2. Local Management of eCTD
Others that have retained the day-to-day eCTD maintenance and lifecycle at a local level
Retaining eCTD maintenance and lifecycle at a local level can be a costly activity.
While the local contact might have all the national documentation requirements and the regulatory history behind the marketing authorisation, the cost involved in training and issuing eCTD software licences to each local affiliate/partner can be costly. In addition, company-wide eCTD dossier and structure format is hard to maintain when different affiliates/local partners are working in isolation.
3. Companies that have outsourced eCTD entirely
Others have moved to outsource their eCTD publishing for various reasons. Many smaller companies do not wish to invest in eCTD software and the intensive and expensive training that staff must undertake to best utilise the eCTD software. Others simply choose to channel their energies into commercial efforts, and they outsource the eCTD publishing to third party providers.
We Can Help
Acorn Regulatory has a dedicated team of eCTD experts working with clients. The team, led by Eileen Ryan, can advise you on the best strategy for your company and can help you with all of your submission related issues. Contact us today to see how we can help. Complete the form below or contact us on 00353 52 61 76 706.