COVEX expands it global presence.
COVEX projects have always reached to global markets, but until now all global operations were managed from the main office in the United States. COVEX understands that in order to continue to offer the highest quality services at affordable prices, internal expansion is required that staffs local resources in the regions where the work will be performed.
During 2008, a working relationship was initiated with Interface Infotech, Inc., which is a locally based South Korean (Seoul) company that specializes in the business of development and implementation of laboratory related software and computer systems. The trigger for this relationship was a shift in existing trade agreements between the US and South Korea . Drug companies in South Korea will soon be able to export generic drugs into the US market, which will require them to be compliant with FDA requirements for drug manufacturing, testing, transportation, and storage (among other things). As a result, these companies understand that a key component of achieving this compliance is to properly validate their computer and automated systems that control their operations. The KFDA (Korean FDA) is also imposing similar requirements for computer and automated system compliance as well as control over electronic records and signatures associated with modern data management and drug processing / manufacturing systems (similar to the requirements associated with 21 CFR Part 11 in the US).
As a result of this new market opening for the South Korean drug manufacturers, inquiries began coming into Interface Infotech, Inc. for Quality Management System development and computer system validation services. As Interface Infotech, Inc. was already heavily tied into the drug maker market as a result of their state of the art LIMS and data management systems, it became an easy, trustworthy transition for them to provide computer validation services to their clients.
Interface Infotech, Inc. reached out to COVEX to support the initial two efforts in which they were engaged by CJ Pharma and Choongwae. COVEX support was requested to assist in the development of standard Quality Management Systems and Computer System Validation lifecycle methodologies (as well as complete compliance policies and systems to accompany), that mimic the current systems used by US drug manufacturers today to satisfy the requirements set forth by the FDA.
Successful completion of these projects initiated additional requests for work by the South Korean drug manufacturers. At that point Interface Infotech, Inc and COVEX decided to begin discussions on creating a separate unique entity in South Korea, one that could service not only the Korean peninsula, but additional Asian markets as COVEX services continue to expand in that region. In the last quarter of 2008, the companies filed the necessary agreements and paperwork and formally created “코벡스코리아 주식회사”, or “Covex Korea Co., Ltd.” in English.
The establishment of this company not only expands COVEX’s ability to offer quality, lower cost services outside the US borders, but also is succeeding in spreading good quality and validation practices to those countries not currently under US regulatory requirements. The partnership helps spread knowledge of drug manufacturing and control between two cultures, which in the long run we expect will make a positive impact on both regions. There is much to learn from the time hardened engineering and manufacturing practices in which both regions have successfully engaged in for decades.
COVEX Korea Co, Ltd. is excited to offer world class quality and compliance services to the Korean and Asian markets. A fully US trained team of South Korean based consultants has been and continues to be developed. New employees of COVEX Korea go through the same rigorous training as the employees of COVEX, including project mentoring. COVEX Korea resources will be trained by senior COVEX consultants, in most cases in the US . In addition, all projects will be fully supported by assigned US based senior COVEX resources which will whenever possible be provided on project sites in Asia . COVEX believes in a “hands on” approach to successfully accomplishing projects and is eager to support all Asian efforts identified through COVEX Korea as necessary.
Please find out how COVEX and COVEX Korea can assist you with your next compliance activity either in the US , or abroad!
Covex Korea Contact Information
Jeong-Min Park
+82-2-443-3274
+82-2-2082-7514 (fax)
605, Kolon Digital Tower Aston,
5 05-14, Gasan-Dong, Geumcheon-Gu,
Seoul, Korea, 153-803