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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