Scope
This is with assumption that the technical and legal documentation are available and already submitted. The focus of the scope should primarily be on:

-Query management
-Regulatory follow-ups
-Liaison with CDSCO reviewers
-Progression of existing submissions

In-person visits to the reviewers in Delhi required to move the applications forward.

Such liaison visits may be required to:

Review the application file with the reviewer
Understand the exact reason for pending status
Clarify if additional documents/explanations are required
Confirm the next expected review step

If the application status remains unchanged after submitting responses, follow-ups or meetings with CDSCO officials may be required to ensure the application progresses to the final approval stage.

Communication & Status Updates
To ensure clarity,



we suggest defining transparent communication updates for each application.

Updates should include:
After every follow-up (email / portal / visit):

-Current SUGAM status
-Summary of communication with CDSCO
-Any concerns or issues raised by the authority
-Additional documents or clarifications requested
-Expected next step in the review process

If an in-person visit is conducted, a short summary should be shared within 48 hours, including:

-Date of visit
-Officer/department met
-Discussion summary
-Action points from CDSCO
-Any required submission from our side
-Expected next timeline or follow-up
Hiring #RegulatoryAffairs #CDSCO

📌 CDSCO Regulatory Liaison (India)
🏢 Access-2-Healthcare
📍 India