Dossier-Mgmt© | SPT

A Ready-to-use, Cost Effective & Regulatory guidelines compliant software solution

To create and manage regulatory guidelines compliant and validated eCTD Submission has become very critical activity. Region-wise requirements are different and its really challenging to manage them while Submission Building, Validation & Correction Activity.
Software plays vital role to Create, View + review, Validate,Publish and Manage lifecycle of Submission. Easier and User-friendly interface tonesdown efforts of RA team in preparation, validation and correction activity.

Ready-to-use Enterprise Version for Countries as per Latest Guidance as mentioned below:

  • Updated with latest Regulatory Authorities requirements
  • Lightweight, very simple & User-Friendly Interface with minimum training required
  • Major Regulatory Market requirements are managed like US, EU, CA, ZA, GCC, AU, CH etc. along with non-regulated markets
  • Assured validated and compliant output
  • Web-based Application – Start using with minimum Server and Client Machine requirements | No specialized software OR hardware is required
  • Powered with Adobe PDF library to perform PDF properties related activities like correction and verification in the most standard way
  • Manges Hyperlink, Bookmark activity in easier, faster way; Quick / Auto / Copy / Auto-correct features helps to avoid redundant activities of Hyperlink in each and every submission
  • User & Super-User Dashboard to present Submissions using Graphical Interface
  • eCTD file names and Titles are as per the regulatory requirements
  • Multi-user system which support parallel working on same or different submissions with controlled access permissions
  • Audit Trails for each and every activity in compliance with 21 CRF guidelines
  • Secured View for External Users
  • Migration / Import activity for third party Submissions
  • Minimum software & Hardware requirements, speedy installation & validation activities
  • Cloud-based interface enables quick submission preparation, review & publish
  • Integrated with RSCM [Regulatory Submission Content Manager] to maintain document life-cycle
  • Services
  • Regulatory Services
  • SPL Services
  • Software Product
  • Dossier-Mgmt© | SPT
  • Structured Product Labeling
  • DocsExecutiveTM
  • Regulatory Submission Content Management
  • eTraining
  • Submission Event Management Software
  • Corrective Process & Preventive Process
  • Change Control Process
  • Deviation
  • Industries
  • Pharmaceuticals
  • Generics
  • Company
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