SYNAPSE ELECTRONIC PUBLISHER
A Dossier Submission Tool
Dossier Submission made easy
Synapse electronic Publisher (SeP) is a new generation submission tools that enables the pharma companies to perform their dossiers submission to Health Authority at ease.
SeP in an overview, is an eCTD Software to compile your eCTD dossiers effortlessly with immaculate precision taking into consideration all the norms as framed by the regulatory authorities.
Publish & Submit
Multi-region pre-defined template for submissions in a compliant manner with country specific requirements.
Project metadata compilation, template management and Dossier lifecycle management.
System internally manage the PDF properties like PDF Version 1.4 as per ICH specification.
The tool validates the project for submissions with backbone XML validation and checksum verification.
Submission Query Management
Track all activities from creation to submission, amendments and query responses.
eCTD dossier submitter can manage large amount of sequence easily by loading a lifecycle, eCTD documents and folders in local drive and network shared device.
The SEP Advantage
- Investigational New Drug Application/Clinical Drug Application (CTA)
- New Drug Application/Marketing Authorization Application
- Abbreviated New Drug Application
- Drug Master File/Active Substance Master File
- Biological License Application
- Electronic Common Technical Document (eCTD) and Non- eCTD electronic Submissions (Nees)
- Region specific eCTD Dossier publishing & submission planning and life cycle management
- Compliant with US FDA and EU EMA