Regulatory Information Management

Regulatory Information Management


We provide our clients with a complete solution to plan, manage, publish, transmit, and archive regulatory submissions and agency correspondence throughout the products 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

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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

Collaborative Authoring

  • Develop/Improve and train on the author, review,

  • and approval process for submission-related documents

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

Submission Transmission

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

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

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