Regulatory Information Management

Our services are designed to provide our clients with a complete solution to plan, manage, publish, transmit, and archive regulatory submissions and agency correspondence throughout the products lifecycle.

Consistent Standards

We focus on looking across the activities during the products lifecycle to ensure data flows freely and efficiently across your organization, using a compliant and consistent standard.

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

Project Strategy and Management 

R&D Systems Implementation

R&D Process Development and Training

Data and Document Migration Planning

Acquired Asset Transfer

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!