Quality Assurance through Global Certifications

Prestige Biologics provides biopharmaceutical development and manufacturing services supported by globally compliant quality systems and production capabilities.

Expansion of Global Certifications

The company has obtained GMP certifications from the Korean Ministry of Food and Drug Safety (MFDS) and the European Medicines Agency (EMA), and continues to expand key regulatory certifications to support global biopharmaceutical manufacturing.

Plant 1 at Campus 1 is currently operating under MFDS GMP and EMA GMP certifications. Plants 2, 3, and 4, which are being developed in phases, are also undergoing certification processes in accordance with global GMP standards. In line with the company's CDMO roadmap, FDA cGMP certification is also being pursued in a phased approach.

Global-Standard Quality Management

The large-scale storage and warehousing facilities within Plant 4 are operated under a management system based on WHO Good Distribution Practices (GDP) standards, ensuring global-standard quality management and control.

Prestige Biologics continues to strengthen its certification framework in line with global regulatory requirements while leveraging its quality management capabilities to provide reliable manufacturing support for customers' biopharmaceutical products worldwide.