Medicilon/MPI Preclinical Research-Shanghai has recently expanded their service offerings to provide Sponsors with the ability to conduct studies that meet the FDA’s Good Laboratory Practice (GLP) regulations, at their Chuansha facility in Shanghai, China.
Bob Sigler, a consulting toxicologic pathologist and president of vet pathology and IND Services, has validated qualifications of the Medicilon/MPI Preclinical Research-Shanghai facilities.
Dr. Sigler said: “The lab is a state-of-the-art facility optimally designed for GLP toxicology-safety as well as efficacy studies. The talented staff is taking full advantage of having the onsite experienced MPI Research staff present for training and operations as well as integration of Standard Operating Procedures (SOPs). This combination provides high quality studies at an excellent value for clients of Medicilon/MPI Preclinical Research-Shanghai.”
Mary Ann Scott, senior director of regulatory operations at MPI Research, said: “The dedicated GLP Advisory Board, from MPI Research, has worked diligently throughout the past year to train local staff in order to achieve USFDA GLP compliance.”
The newly formed company, which recently announced its full International Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) accreditation, has also received an accreditation from the Shanghai Laboratory Animal Commission.
Jintao Zhang, CEO, said: “Bringing US FDA GLP to China was always a part of the initial strategy of the company,”
Dr. Stephen Porter, CSO – Asia at MPI Research, said: “Another key milestone has been achieved by the joint venture between MPI Research and Shanghai Medicilon. We have advanced our product lines of services from non-GLP PK/PD/Tox, to a US spec GLP Toxicology facility. This achievement is the culmination of nearly eighteen months of close cooperation between Shanghai Medicilon and MPI Research GLP teams, and demonstrates exactly the kind of mutual benefits we anticipated when we entered into the JV agreement. We’re looking forward to new projects and expanding global relationships to meet the future challenges of advanced GLP testing.”