eCTD & Electronic Publishing Services
Acorn Regulatory has a dedicated eCTD & Electronic Publishing team based at our offices in Ireland that can assist you with every aspect of your submissions.
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. Feel free to get in touch with us today.
Our team frequently write about issues related to the sector and you can read a sample of what they have written here.
Acorn Regulatory can provide an array of eCTD services that could assist you in the transition to eCTD.
- eCTD publishing of all submissions or as an eCTD publishing back-up for any urgent sequences required, lifecycle management, validation for all published sequences, submission to the relevant health authorities
- Conversion of NeeS or paper dossiers to eCTD for Baseline submissions
- outline company strategy to implement a standard structure, format and granularity of eCTD dossiers submitted
- Training in Electronic submissions
Now that the implementation of mandatory use of eCTD format for regulatory submissions within the European Union has arrived, there are some eCTD issues that should be evaluated for any company.
- How many of your marketing authorisations will we need to submit a baseline submission?
- How many licences already have fully compliant CTD sections to create a baseline and how many will require more resources to create CTD formatted dossier sections?
- Do you have a company standard structure, format and granularity of dossier sections in place to enable an efficient lifecycle management throughout our range of products?
- Is this format compatible with the reuse of sections for other territories?
- Can your publishing team handle the increased workflow?
- Should some or all publishing activities be outsourced temporarily or permanently?
- Have staff been adequately trained on eCTD? Is further training required?
- Do internal or external staff need to be trained as a back-up for any urgent submissions that could arise?
We can assist with all of the issues referenced above and more.
We have a dedicated eCTD & electronic publishing team. They can assist your company with your publishing requirements. Call us today on 00353 52 61 76706 or complete the webform below and we will get back to you.