Create Your Own Custom Milestones!

Sample Milestones for Regulatory Submissions

Dynamic Milestone Manager will transform the way medical device and pharmaceutical companies track, manage, and optimize regulatory submissions. With its intuitive, flexible framework, Dynamic Milestone Manager ensures every critical regulatory deadline, document, and approval is organized, captured, tracked, and managed with precision. From initial submission preparation to final approval, our solution allows teams to stay aligned to document and ensure compliance at every step. Empower your regulatory affairs leaders with tailored milestone tracking, and real-time status updates—helping your teams reduce delays, improve collaboration, and streamline the complex regulatory submission process, all while maintaining full compliance and visibility across departments.

Sample Milestones

New Submission USA

  • Pre-NDA Meeting with FDA

  • Submission of Clinical Trial Data and Documents

  • FDA Application Acknowledgment

  • FDA Review Period Begins

  • Request for Additional Information from FDA

  • FDA Approval Notification

  • Labeling and Packaging

  • Finalization

  • Drug Launch Notification

    EU Medical Device Renewal Submission Milestones

  • Review of Current Certification Status

  • Pre-Renewal Submission

  • Review

  • Submission of Updated Product Information

  • Risk Assessment and Compliance Checks

  • Clinical Trial or Study Data Review

  • Post-Market Surveillance Report Submission

  • Renewal Approval from EU Authorities

  • Updated CE Marking Issued

    Mexico Renewal Milestones

  • Review of Previous Stent Approval Documents

  • Submission of Renewal Application

  • Request for Updated Clinical Data

  • Regulatory Review Period

  • Approval for Continued Market Availability

  • Renewal Notification Sent

  • Product Labeling and Compliance Updates

  • Stent Distribution Resumed

    China New Submission Milestones

  • Pre-Submission Document Preparation

  • Regulatory Application Submission

  • Application Acknowledgment from AuthoritiesInitial Review Meeting with Regulatory Body

  • Additional Information Request Response

  • Clinical Trial Data Submission

  • Regulatory Approval Granted

  • Product Registration Complete