Submissions Key Factors

Why is MasterControl Submissions Gateway? Right for You?

MasterControl Submissions Gateway is an out-of-the-box application that can be integrated with leading e-submission tools, connecting approved documents and forms-based content with the submission assembly process, to accelerate the submission process.

Here are some of its features that help ensure your system is always Compliant, Connected, and Complete:

Compliant.

Sustained Compliance:

  • Streamlines submission creation process and provides proper format for each FDA center
  • Is an off-the-shelf configurable product designed for rapid installation, implementation, and validation
  • Avoids submission delays caused by Part 11 noncompliance

Connected.

Integrated Quality Management:

  • Connects intuitive document control, submission assembly and publishing features to accommodate last-minute inclusions
  • Links audit trail and approvals to improve submission quality thereby reducing time spent in Q&A with FDA agencies
  • Integrates drag-and-drop functionality for accelerated submission organization and assembly
  • Helps automate a variety of submission types including NDA, BLA, SNDA, CTD, ANDA, IND, etc.

Complete.

Enterprise-wide Product Application: MasterControl believes that quality initiatives must be integrated into an organization's corporate culture. The MasterControl solution helps companies ensure that quality standards are enforced across the enterprise. Its platform is powerful enough to meet the needs of every department in an organization � R&D, clinical, quality control, and regulatory affairs. Its robust features enable compliance with various regulatory requirements.





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