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.