Business Imperatives

  • A Switzerland-based biopharmaceutical company partnered with Freyr sought regulatory operations support for a monoclonal antibody product in China.
  • The company required a timely end-to-end execution for sample testing and dossier submission that was aligned with China NMPA guidelines.

Objectives

To facilitate the successful execution of sample testing and Regulatory documentation for a monoclonal antibody product by coordinating with China’s National Medical Products Administration (NMPA) and ensuring alignment for BLA submission

Problem Statement

  • The client faced strict timelines and complex documentation review processes that were in line with evolving NMPA requirements.
  • Without proper Regulatory alignment, the submission risked delays, potentially impacting the review and approval of the BLA.
  • Efficient coordination with NMPA and minimizing risks in sample and test method transfer were critical to maintaining progress.

Freyr Solutions and Services

Freyr Solutions and Services

Freyr provided comprehensive Regulatory operations support, including:

  • Coordination of test sample and dossier preparation with global stakeholders
  • Import and delivery of samples to NMPA test center
  • End-to-end query management and communication with the NMPA test center
  • Identifying risks and ensuring test method alignment with NMPA to prevent delays

With tight timelines, Freyr successfully mitigated the risks of non-alignment through early and proactive communication with NMPA. The sample testing was completed as per the technical and Regulatory requirements, allowing timely support for the BLA review process.

  • Strong technical and Regulatory support for seamless BLA testing
  • Prompt submission support in compliance with NMPA requirements
  • Minimized delays through proactive risk identification and alignment
  • Optimized Regulatory Process for the Chinese market