How We Help

The Submissions Coordination team provides strategic and tactical support for the binder building process. Our dedicated team of Submissions Coordinators has a deep understanding of MLR, Veeva Vault PromoMats, and binder preparation, and is supported by an experienced team of MLR and Regulatory Operations Managers who understand the importance of timely, accurate compilation and submission of content.

Principal
Joanna Bova, PMP - Executive Director, Process Management

Joanna Bova, PMP
EVP, MLR Solutions

Principal
Joanna Bova, PMP - Executive Director, Process Management

Joanna Bova, PMP
EVP
MLR Solutions

Frameworks Submissions Coordinators provide Strategic and Tactical Support for the binder building process    We do this with a dedicated team of submission coordinators who have a deep understanding of MLR, VEEVA Promomats, and the binder preparation process.   Our Submission Coordinators are supported by an experienced team of internal MLR & Regulatory Operations Managers which understand the importance of timely and accurate compilation and submission of content.

Services include:
  • Monitor Submissions Coordinator queue

  • Manage trackers for accelerated, pre-clearance, and 2253 submissions

  • Ensure alignment with meta data and dates for accuracy and compliance
  • Complete required workflows
  • Complete tactical execution of binder creation, including:

    • Compile promotional material(s)
    • Include required supporting documents
    • Ensure inclusion of appropriate PI
    • Prepare draft/blank submission form
    • Submit to Regulatory Affairs
Service Delivery

Service Delivery

Our Submissions Coordinators seamlessly cross collaborate with your current staff throughout the entire Binder Build Process

Service Delivery

Service Delivery

Our Submission Coordinators seamlessly cross collaborate with your current staff (stakeholders/owners could either be in a PRC / Regulatory or both) throughout the entire Binder Build Process

Our team completes secondary internal reviews of all materials
to ensure accuracy prior to submission to Regulatory Affairs

Our team completes secondary internal reviews of all materials to ensure accuracy prior to submission to Regulatory Affairs

The Frameworks Difference

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Transformation through Collaboration