SUBMISSION TIMELINES AND TRACKERS

On track and on time.

Timelines are the cornerstone of any successful submission and should serve as an informed playbook covering every document needed. Creating comprehensive and adaptable submission timelines requires experience and lots of time to set up and manage. Let Acumen help!

See how it works:

Overview of Acumen’s submission timelines and trackers:

  • Utilizes Smartsheet’s core functionality, enriched with instructions and suggestions from Acumen’s submission managers

  • Covers all eCTD sections and modules for regulatory submissions

  • Includes timelines specific for each eCTD document, with sequencing for maximum efficiency and suggestions for content flow

  • Allows for easy, real-time progress tracking with visualizations to highlight bottlenecks

  • Provides forecasting of key submission milestones, informing cross-module integration

  • Creates contact lists to assign and track medical writing, reviewer and approver tasks

  • Enables sharing and team collaboration via the cloud-based Smartsheet platform

  • Timelines and trackers are exportable in a variety of formats

All subscriptions come with an onboarding session with Acumen project managers to ensure you are optimizing your tool set. If needed, ongoing submission timeline management support is available through Acumen.   

Lead Your Regulatory Submissions with Confidence

Acumen has built fully integrated and linked timelines and document trackers in Smartsheet for all eCTD modules, specifically aligned for IND, NDA, and BLA submissions. 

Our toolset was developed by the Acumen submission team, comprised of experienced submission managers, and informed by clinical and nonclinical writers, editors, and publishers. Acumen’s teams have successfully shepherded clients through dozens of submissions and have infused this hard-earned experience right into our timelines and trackers.