Business Imperatives

A U.S.-China-based biopharmaceutical company required Regulatory support to address China NMPA’s stringent requirements for high-risk products. The product in question—a blood-derived therapy—was selected for an overseas on-site inspection, critical for market approval in China. The client needed:

  • Preparation of Regulatory dossiers aligned with NMPA expectations
  • Real-time coordination of NMPA’s global on-site audit
  • Language support and guidance during inspection to mitigate compliance risks

Objectives

To support a U.S.-China-based company in achieving a successful overseas on-site inspection by China’s National Medical Products Administration (NMPA) for a high-risk, blood-derived product, ensuring uninterrupted market access and Regulatory compliance.

Problem Statement

The client encountered the following key challenges:

  • High-risk Product Classification: NMPA classified the blood-derived product as high-risk, triggering an overseas audit.
  • Regulatory Scrutiny: Misalignment with inspection expectations could lead to delays or loss of market qualification.
  • Operational Complexity: Coordinating audit logistics and communication between global sites and NMPA officials was resource-intensive and time-sensitive.

Freyr Solutions and Services

Freyr Solutions and Services
  • Prepared the complete Regulatory dossier tailored to NMPA’s audit expectations
  • Scheduled and coordinated the full on-site inspection process between global teams and NMPA officials
  • Provided bilingual support for real-time Q&A and issue resolution during the inspection
  • Regulatory Continuity: Seamless inspection enabled uninterrupted access to the Chinese market
  • Operational Efficiency: Timely coordination avoided delays or re-inspection scenarios
  • Compliance Confidence: Informed, real-time support reduced Regulatory risk during the audit

Freyr successfully enabled a smooth inspection process with zero compliance flags. The NMPA audit was completed on schedule without impacting the product’s marketing authorization in China.