Compliant With Worldwide Regulations

  • Entirely abides by ICH and drug registration regulations in nations across the world, currently being adopted by 80% of regulatory agencies

  • Built in non-eCTD modalities, including NeeS, VNees, ACTD, IDMP, etc

  • Built-in eCTD requirements for all applicable regulatory bodies, including USA, EMA, Canada, Japan, GCC, Thailand, etc

Comprehensive Electronic Submission Solution

  • Rapid response to the latest regulatory changes worldwide

  • Seamless integration with electronic submission gateway for various regulatory bodies for convenient and compliant submission

  • One-time purchase includes complimentary upgrades when available (including regional module changes, eCTD/non-eCTD version upgrades)

All-In-One Functionalities: Publishing, Submission and Validation

  • Effective document publishing tool, with support of simultaneous publishing, submission and validation, correcting errors at any time

  • Supports automatic conversion of Word document to PDF

  • Built-in validation tools for global submission with automatic matching with country of submission

Simplify Product Lifecycle Management

  • Highly elaborate hyperlinking and bookmarking management

  • Various modes of query search and browsing of submission details

  • 1 basic installation package + additional user to be added at anytime, with support of multi-end users working cooperatively

Seamless Integration with Document Management System (DMS)

  • Taimei eArchives
  • EMC Documentum
  • Microsoft SharePoint
  • QUMAS/Biovia
  • NextDocs 
  • CSC
  • Infotehna
  • OpenText
  • d.velop
  • Master Control

Reliable and Easy to Use

  • Stable and high-performance system used in 60+ countries and 700+ clients worldwide

  • Easy installation and configuration

  • Straight forward user interface with minimal training required to use

Instant and Professional After-Sales Support

  • Customized registration submission and eCTD solutions according to project needs

  • 24*7 one-to-one service with free technical consulting related to software operation

  • Expertise from experienced consultant from regulatory bodies and industry to provide regulatory and technical supports