Certificates

 

CDEMO service of Prestige Biologics
Providing the best solution for Biomanufacturing

Product guarantee through international standard certification
Quality Assurance by Global Certificates

Prestige Biologics provides technology services tailored to global standards.

Prestige Biologics obtained European GMP approval following Korean MFDS GMP approval. In order to support technology development and production of global biopharmaceuticals, we are additionally proceeding with major certifications according to a systematic roadmap. The US FDA cGMP approval process is also being carried out according to the CDMO management roadmap.
Currently, we have Korean and European GMP certifications for our 1st factory facilities on the 1st campus, and the 2nd, 3rd, and 4th factories, which are in the process of establishing according to the schedule, are also in the process of obtaining GMP certification.

In addition, we have obtained certification that meets WHO’s GDP requirements, and manage and control the large-scale storage and storage facilities in the 4th factory according to global standards.

Prestige Biologics is strengthening quality assurance services for biopharmaceutical production for global customers by continuously expanding major global certifications.

EU EMA GMP certificate

Certificate of GMP Compliance of a Manufacturer awarded
by EMA (No. ES/017/22).

MFDS GMP certificate

Certificate of GMP Compliance of a Manufacturer awarded
by MFDS (No. 2646)

GDP certificate - Storage & Distribution

Certificate of GMP Compliance of a Manufacturer awarded
by MFDS (No. 2646)

ISO certificate for management

Certificate of ISO 9001:2015, KS Q ISO 9001:2015 awarded
by KMR (No. RQM7628)

ISO 14001

ISO certificate for Environmental Management System

Certificate of ISO 14001:2015, KS I ISO 14001:2015
awarded
by KMR (No. REM3193)

ISO 45001

ISO certificate for Occupational Health and Safety Management System

Certificate of ISO 45001:2018/KS Q ISO 45001:2018
awarded
by KMR (No. ROH1849)

From clinical development to commercial production

Prestige Biologics provides various services such as analysis service, clinical development, clinical sample production, clinical secondary packaging (double-blind packaging), process development, and commercial production. We respond flexibly to the needs of customers of various needs, such as CDO, CPO, CMO, and CEO. We are also always open to partnerships that develop potential.