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Medicilon/MPI Preclinical Research-Shanghai Offers US FDA GLP Services

2009-12-08 16:36
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SHANGHAI, China--(BUSINESS WIRE)--Medicilon/MPI Preclinical Research-Shanghai has recently expanded their service offerings to provide Sponsors with the ability to conduct studies that meet the US FDA Good Laboratory Practice (GLP) regulations, at their Chuansha facility in Shanghai China.

Bob Sigler, DVM, PhD, DACVP, a consulting toxicologic pathologist and President of Vet Pathology and IND Services, has validated qualifications of the Medicilon/MPI Preclinical Research-Shanghai facilities. “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,” says Dr. Sigler.

Medicilon/MPI Preclinical Shanghai, founded in December 2007 by parent companies MPI Research and Shanghai Medicilon, has been operational since February, 2008.

The two companies came together to meet the growing needs of the multi-national pharmaceutical and biotech industries. The drug and medical product submissions of these companies are required to meet regulatory standards, including US FDA GLPs. China-based companies seeking approval to market their products internationally must also meet these standards.

Mary Ann Scott, Sr. Director Regulatory Operations at MPI Research noted, “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.

Bringing US FDA GLP to China was always a part of the initial strategy of the company,” says Jintao Zhang, PhD, CEO.

Dr. R. Stephen Porter, CSO - Asia, MPI Research, added “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.”

Medicilon/MPI Preclinical Research-Shanghai is continually looking for ways to meet the needs of the industry. The company has a dedicated team that provides high-quality, timely service. This team ensures top quality research by modeling their parent companies in the following ways: superior systems, proper SOPs, extensive training programs, an active QA staff and recruiting the best talent in the industry.

Medicilon/MPI Preclinical Research-Shanghai, located in the Chuansha Economic Park in Shanghai, China, provides global pharmaceutical and biotechnology companies with high quality preclinical drug discovery and development studies in an Asian facility that meets worldwide regulatory standards.

For further information on Medicilon/MPI Preclinical Research-Shanghai visit medicilon-mpi.com.

Contacts

Jintao Zhang, PhD, CEO
Medicilon/MPI Preclinical Research-Shanghai
021 51320225 8812
info@medicilon-mpi.com