Business Imperatives

A China-based biopharmaceutical company developing a recombinant protein vaccine against COVID-19 required rapid and continuous Regulatory support to align with evolving NMPA guidelines.

The client sought:

  • Ongoing communication with the NMPA and its test centers
  • Regulatory guidance on epidemic-specific policies
  • Rolling submission and weekly updates to accelerate development
  • Technical planning for testing and submissions

Objectives

To provide comprehensive Regulatory and technical support for vaccine development under special epidemic policies, ensuring streamlined communication with the NMPA, and securing timely IND approval.

Problem Statement

The client faced the following challenges:

  • Special Regulatory Policies: Frequent policy changes for epidemic-related products demanded constant updates and alignment.
  • Submission Burden: Weekly updates and rolling submissions created operational complexity.
  • High Dependency on NMPA Communication: Coordination with both the authority and designated test centers was critical for progress.

Freyr Solutions and Services

Freyr Solutions and Services
  • Organized consultation meetings with the NMPA and acted on outcomes as per agreements
  • Facilitated communication with NMPA during early development to receive Regulatory guidance
  • Provided continuous Regulatory support, including weekly updates, rolling submissions, and testing plans
  • Ensured efficient alignment with special epidemic-related Regulatory requirements

Freyr enabled the client to achieve successful IND approval without queries, securing Regulatory clearance under compressed timelines.

  • Smooth Approval Pathway: IND approval achieved seamlessly with no queries raised
  • Strong Regulatory Alignment: Application submission to NMPA within short timeline with strong technical support