Submission Event Management Software (SEMS)

SEMS is software solution which tracks and manages main events for Regulatory Submission post initial Dossier Submission.

Key Features

  • Elaborate management of Queries from Regulatory authorities.
  • Objective of the Software is to reduce Queries for future Drug Products by having detail check list of issues to be taken care during Product development.
  • Provision to enter historical queries and related responses.
  • Provision to define Abbreviated queries based on the communication received from regulatory authorities.
  • Provision to assign each task to different department users to address the relevant queries.
  • Emails, discussion forum and provision to document all communications across departments while addressing queries.
  • Software serves as knowledge base for future drug development.
  • Provision to load relevant guidelines to enable relevant departments while addressing queries.