This regulatory-proven software offers complete document control with powerful dossier assembly and publishing capabilities-right out-of-the-box.

Customers who use MASTERControl Submissions are confident their system is compliant, connected and complete (C³).

Compliant.

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

Connects intuitive document control, dossier 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