FIT FOR PURPOSE

Our program managers have experience leading and managing the content development for regulatory submissions, including INDs and NDAs/BLAs. We integrate into teams of all experience levels to provide the depth of management needed to mitigate common pitfalls and stay on schedule.

We help implement document review infrastructure leveraging Acumen’s extensive experience leading submissions.

WHAT WE DO

• Create and maintain integrated timelines

• Define workflows and develop document libraries and reviewer/approver matrices

• Develop weekly dashboards and facilitate team meetings

• Coordinate with resources across deliverables

• SharePoint set up including eCTD compliant tagging and workflows