Skeletal DossierSave as PDF
eCTD/NeeS format application submissions are standardised by strict specifications regarding the layout and format of documents (e.g. page layout/margins, fonts, header/footers, hyperlinking etc.). To avoid rejection of an application by authorities these specifications should be followed in your eCTD/NeeS sequence.
Pre-formatted documents following the guidelines regarding format conventions allow fast and efficient authoring and help you to meet the company's anticipated deadlines. A complete skeletal dossier providing all necessary documents, broken down to heading-level, minimizes the hazard of creating documents in an incorrect granularity and shape right at the stage of authoring.
Assessors at the Health Authorities will appreciate well-structured dossiers and will not become discouraged by presenting the dossier in a deficient shape.
ERA can identify all important requirements concerning the structure and format of the documents to be submitted. Any regulatory changes will be implemented which always warrants an up-to-date set of documents for compiling your CTD sections. This ensures that you do not have to consider any technical aspects and can concentrate on just the content of your documents.
How can ERA's eCTD group help?
- Provision of guidance-compliant templates (skeletal dossier) for Module 1 to Module 3, and 5.2 if required
- Unified headers and footers, customised according to customer's needs
- Adjustment to A4 and US Letter format depending on authorities' requirements
- Adherence to ICH and local authorities' naming conventions
- Different approaches regarding granularity, depending on the product and submission type
- Easy-to-handle documents, optionally with or without macros and additional toolbars
Are you looking for other product development consulting services independent of eCTD?
- Creation of annotated templates, providing important regulatory guidance on the content of documents
- And other consulting services regarding biotechnological and biological products as specified on our website
For further information on other consulting services please see: www.eraconsulting.com