Project Management

Medical Writing: Clinical

Medical Writing: Nonclinical

QC & Editorial

Narratives

Document-Level Publishing

Publications

Project Management

Medical Consulting

Transparency & Disclosure

Dependable coordination of complicated document development processes.

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