eCTD & Electronic Publishing Services
Now that the implementation of mandatory use of eCTD format for regulatory submissions within the European Union has arrived, there are some eCTD items 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?
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
We have a dedicated 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.