A First for Parexel

The first multipurpose cGMP contract manufacturing facility in South Korea, the Korea Biotechnology Commercialization Center (KBCC), will be validated by Parexel International. As part of an agreement with the Korea Institute of Industrial Technology (KITECH), Parexel Consulting will provide KBCC with a team of on-site validation engineering consultants and regulatory experts to train KBCC personnel, and validate the manufacturing facility, its utilities and process equipment.

"Parexel Consulting's experts will collaborate with KITECH management to position the KBCC manufacturing facility to meet or exceed current FDA and cGMP standards, thus providing a regulatory compliant foundation for future therapies to achieve regulatory approval," said Kurt A. Brykman, president of Parexel Consulting.