Regulatory

Mission3 offers a comprehensive set of solutions to support the entire life cycle of the submission processes to comply with various global regulatory mandates including eCTD, PMA, 510(k) and pre-IDEs.

Our regulatory offerings can be broadly categorized as follows:

• Content Authoring and Document Management tools to create, review and approve the content required for submissions, specifically designed for collaboration and reuse.
• Project Management tools for setting and tracking start/end dates, resources assignments and task inter-dependencies.
• Submission Management tools to assemble and publish the necessary content for specific submission formats for both FDA as well as regulatory agencies around the world.
• Business Intelligence tools that assimilate and analyze data from disparate content repositories to track the progress of multiple submissions and regulatory interactions across products, regions and submission formats.

Mission3's regulatory solutions are integrated with each other out-of-the box and do not require any additional customization. However, they are also available as individual offerings to meet a specific need.