Regulatory Information Management

We help you reduce your regulatory risks by applying process improvements to your existing structures using the most up-to- date good practices, models, and agency recommendations.

Consistent Standards

We can provide you with the assessments you need to make your next decisions towards compliance while maximizing your current or future investments in systems, processes, and resources.

The Complete Regulatory Submissions Lifecycle

Submission Planning and Tracking
  • Identify submission roles/responsibilities
  • Identify submission content and timelines
  • Create and manage project plan 
  • Facilitate Submission Kick-off meeting
  • Conduct submission type, process, and system training
Submission Preparation and Compilation
  • Report level formatting, PDF Publishing, and Submission Readiness
  • Submission level Publishing
  • Support application types: IND, CTA, NDA, BLA, MAA, ANDA, sNDA, NDS, IMPD, Annual Reports etc. 
  • Support format types: eCTD and NeeS

    Submission Archiving
  • Submission Archival Tracking and Maintenance 
  • Health Authority Correspondence Tracking and Maintenance 
  • Health Authority Questions and Response Tracking linked to submissions and other correspondence

      Submission Transmission
  • FDA ESG Gateway Setup and Transmission
  • CESP Gateway Setup and Transmission

        Collaborative Authoring
  • Develop/Improve and train on the author, review, and approval process for submission-related documents

Interested in hearing more about how we can assist your organization with Regulatory Submission needs? CONTACT US TODAY!
The RIM Submission Toolkit:

We understand there’s more to managing your submission than implementing a new RIM system.  That’s why we’ve created the RIM Submissions Toolkit.   The RIM Submissions Toolkit is an end-to-end solution developed to provide our clients with process flows, format and content templates, work instructions, quick reference cards, software, systems, and training required to ensure adherence to company submission standards and regulatory requirements.  Once all components are identified and complete, our team conducts functional area workshops to ensure operational success!