eCTD

image

 

Pharma Cloud eCTD Submission management application automates the electronic submissions of drug applications to regulatory agencies. Our eCTD Submission Manager facilitates the planning, creation, review, approval, publishing archival and management of regulatory filings – product applications and related sequences, You can efficiently manage your documents throughout the submission lifecycle from application planning phase through post-marketing.

 

The application types supported

  • Individual New Drug (IND) Application
  • New Drug Application (NDA)
  • Abbreviated New Drug Application (ANDA)
  • Biologics Application (BLA)
  • Drug Master File (DMF)

 

Key Features

  • 21 CFR  Part 11 compliant
  • Product registrations
  • Support in CDER/CBER submission types
  • Automatic business validations
  • Speed up submission life cycle process
  • Re usability of prior submissions
  • Automatically build and manage study tagging files (STFs)
  • Electronic submissions of amendments, supplements and annual reports
  • Role based security access privileges and control
  • Security management
  • Workflow management
  • Document granularity
  • PDF hyperlinking
  • Audit Management

 

Features

  • Submission road map
  • Planning submission dates
  • Create application
  • Personalized dashboards
  • Work in progress / Final preview
  • Automated validations
  • Workflow based approvals
  • Compilation
  • Publishing
  • Archiving
  • Tracking all submissions

 

Benefits

Shorten submission review lifecycle
High efficiency in communication between the sponsor agency and regulatory authorities
Drastically reduce costs
Maximize re usability of data across submissions
eCTD is a harmonized structure that facilitates reusable submission
Option to reuse certain CTD modules for other regulatory agencies like EMEA, Health Canada, etc.

Please contact us for further information at 408-416-3812/512-692-9842