About eCTD Office
eCTD Office is a suite of three integrated NeeS / eCTD software products for the creation, validation, viewing, manipulation and archiving of NeeS / eCTD submissions of regulatory documentation by pharmaceutical companies to the regulatory authorities.
Manage your eSubmissions as simple as 1 - 2 - 3:
1. NeeS Creator
AutoECTD™ plug-in for Adobe® Acrobat® is a NeeS (Non eCTD Electronic Submission) creator tool. It contains a PDF template covering the entire scope of CTD / NeeS / eCTD submissions including all required hierarchical levels in accordance with the current EU/ICH specifications.
2. NeeS Validator
NeeS Validator is an off-the-shelf 2-step Non-eCTD electronic Submissions (NeeS) validation system.
Nees Validator allows for import of the NeeS folder / file structure to report whether the structure conforms to the NeeS format.
3. eCTD Builder
eCTD Builder is an off-the-shelf eCTD (Electronic Common Technical Document) validation, creation, viewing, manipulation and archiving system for electronic submissions.
eCTD Builder lifecycle management features history view of submission sequences, allowing the user to approve documents, search, preview, etc.
eCTD Office helps you do the job...
eCTD Office applications are being used by pharma companies and pharmaceutical consultancy companies all over Europe (France, The Netherlands, Belgium, Poland, Spain, Czech Republic, Germany, UK...)
NeeS Validator is being used (and recommended) as the tool to check submission by several EU agencies.