Effective NCE-1 Submission (E2E)-Query Management for FDA

A multi-location-based generic medicinal product manufacturing company approached Freyr for numerous submission-based Regulatory imperatives to be submitted to the United States Food and Drug Administration (US FDA).

The business imperatives were:

• Gap Analysis
• Preparation of NCE-1
• Update of NCE-1
• Submission of NCE-1 (day)

Through Freyr’s support that involves multiple internal stakeholders’-based activity, timely submission of NCE-1 application to the FDA was achieved.

Our medical writing team supported the clients in various document authoring operations and consultations which led to this expedited and compliant project completion.

Here’s the proven case to learn more.