Business Imperatives

A biopharmaceutical company required urgent Regulatory support in China to resolve sample test-related issues for a hormone drug used in the reproductive system.

The client sought:

  • Technical issue resolution with the NMPA-designated test center
  • Clarification and follow-up on test findings to resume approval progress
  • End-to-end Regulatory coordination for IND clearance

Objectives

To provide Regulatory and technical support in resolving complex sample test issues for a hormone drug under BLA evaluation in China, ensuring smooth communication with the NMPA, and securing IND approval.

Problem Statement

The client faced the following challenges:

  • Test Complexity: The biological product test was technically complex and a key factor in delaying approval.
  • Review Disruption: Issues flagged by the test center significantly halted the review and approval process.
  • Limited Visibility: The client lacked clear insight into the root cause of delays and required in-country coordination.

Freyr Solutions and Services

Freyr Solutions and Services
  • Engaged with the NMPA test center to identify and understand the root cause of the technical issues
  • Coordinated with global Regulatory teams for alignment and support
  • Ensured constant follow-up to resolve all test-related concerns
  • Provided clarity and Regulatory direction to move the IND process forward
  • Timely Resolution: Cleared technical barriers that had stalled the test process
  • Improved Submission Continuity: Enabled uninterrupted progress in the BLA process for China

Freyr successfully resolved the technical issues raised by the NMPA test center, enabling the client to obtain IND approval and unlocking the next phase of their Regulatory journey in China.