Business Imperatives

  • A China-based biopharmaceutical client sought Regulatory support for a Cell and Gene Therapy (CGT) product.
  • The company required IND application execution and strategic planning to align with China NMPA Regulatory pathways for breakthrough therapies.

Objectives

To facilitate successful IND submission and Regulatory consultation for a CGT product by coordinating with the National Medical Products Administration (NMPA), ensuring technical documentation, query resolution, and conditional approval readiness.

Problem Statement

  • The client faced challenges in reviewing and aligning documents with NMPA’s evolving requirements.
  • The CGT platform used cutting-edge technology with limited Regulatory precedent or guidance in China.
  • Timely response to NMPA’s complex CMC-related queries was crucial to prevent application delays.

Freyr Solutions and Services

Freyr Solutions and Services

Freyr provided end-to-end Regulatory operations support, including:

  • Timely response to NMPA queries—4 days ahead of the deadline, enabling smooth IND approval.
  • Consultation on major CMC changes and clinical trial document management (including IND dossier, DSUR, and EoPI).
  • Planning for conditional approval and priority review pathways to accelerate time-to-market.
  • High-quality communication materials and documentation support
  • Strategic planning for priority and conditional pathways

Freyr ensured smooth IND approval on time through proactive engagement with NMPA and expert consultation throughout the application cycle. All Regulatory submissions were aligned with technical expectations and met communication standards.