CDSCO Regulatory Liaison

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 clear 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

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