Regulatory / eCTD Submission

Document and Project Management & eSubmissions (eRegulatoryIntelligence)

Ecomplianceplus dedicated team of regulatory experts ensures that our product is updated from time to time as per latest guidelines, ensuring best practices for our clients.

eRegulatoryIntelligence provide a controlled process for creating, reviewing and publishing documents used for the initial submission to marketing authorization application and then after for product life cycle management which involves moving from manual process to system-based process for better control, traceability and accountability of the dossier preparation tasks.

eRegulatoryIntelligence provides most flexible and scalable regulatory compliance suite for small startups to large enterprises achieving superior quality, in compliance with MHRA, EMA, FDA and other regulatory agencies.


Key Features

Preparation of eCTD or NeeS format Documents

eRegulatoryIntelligence is a platform, consisting of various modules for the pharmaceutical industry.

  • Process driven work-flows
  • Task management
  • Email notification
  • Electronic signature
  • Import & Export
  • External content sharing
  • Submission database
  • Track regulatory events
  • Authority correspondence
  • Reporting engine
  • Manage SOPs and forms
  • Distribute to employee and track training records

Core Features

  • Always compliant to latest ICH guidelines
  • Importer for eCTD’s/NeeS/CTD
  • Create and check hyperlinks
  • Manage eCTD lifecycles
  • Manual compilation of eCTD
  • Manage eCTD meta-data
  • Also publish CTD and NeeS
  • Global eCTD Management
  • Multiple users work in parallel
  • eCTD viewer (delta, sequence, cumulative)
  • Share submission output via portal
  • Re-use eCTD across the organization
  • Re-use documents for multiple eCTD

Key Modules

All in one place and easy to access.

eRegulatoryIntelligence Advantage

Modules and Work-flow