Business Imperatives

  • A Hungary based client sought Regulatory operations support for their API in South Korea.
  • The company required Regulatory transfer & holding of K-DMF in South Korea.

Objectives

To support a Hungary-based pharmaceutical company with regulatory transfer and K-DMF holding for their API in South Korea.

Problem Statement

The client faced the following challenges:

  • Uncertainty in Process Order: Unsure whether to complete the MA transfer first or address pending variations beforehand.
  • Documentation Confusion: Lack of clarity on which documents needed to be prepared and submitted for each step.

Freyr Solutions and Services

Freyr Solutions and Services
  • Analysed the client's specific regulatory requirements and advised on the correct order of operations to ensure a smooth transition.
  • Recommended comprehensive solution to avoid complications in approvals.
  • Assisted in identifying and preparing the necessary documentation required for both the MA transfer and variations, ensuring compliance with regulatory standards.
  • Clarity & Efficiency: The client gained a clear understanding of the correct process, eliminating confusion and ensuring a structured approach.
  • Regulatory Compliance: By following the proper sequence, the client minimized regulatory risks and potential delays.
  • Time & Resource Optimization: With our guidance, the client prepared all required documents in an organized manner, preventing rework and inefficiencies.

Freyr enabled a streamlined Regulatory process with complete documentation clarity, minimizing delays and ensuring compliance with MFDS requirements.