Preclinical Services
Preclinical Services Sheet
Pharmaron provides Western-level regulatory-compliant drug development services from our world-class facility in Beijing. Pharmaron is known for its extensive work in IND-enabling general toxicology studies, including working with vaccines. Recently, Pharmaron has added safety pharmacology capabilities. The company 's AAALAC-accredited facility in China was among the first labs to perform GLP studies for clients worldwide and numerous IND packages based on data generated in our facility have been filed and accepted by US, EU and Asian regulators. The facility was audited by the US FDA in 2009.
Our laboratory is an approximately 84,000 square foot, purpose-built laboratory with full barrier animal rooms, formulation areas, diet preparation areas, analytical/bioanalytical chemistry bench support, histology areas, necropsy rooms, and aseptic surgery suites. A second vivarium is under construction (scheduled to open in December, 2011) and will provide over 100 additional animal rooms adjacent to the current facility.
Track Record
- Over 20 IND packages have been submitted/accepted in support of global regulatory filings (US, Europe, Canada, and Asia) with data from the facility
- Data have been used to support later phase clinical trials (both phase II and III)
- More than 560 studies conducted ranging from acute to chronic studies in multiple species (rodents, rabbits, canines, and non-human primates)
- Species capabilities: Rodents, rabbits, canines , mini-pigs, and non-human primates
- Ensure compliances with US FDA, OECD and US EPA
- Robust regulatory history by client, consulting third party, and FDA audits/inspections
Fully Accredited Facilities
- English SOP's, protocols, data collection and reporting
- Use of ProvantisTM data acquisition software
- Integrated program management
- US board-certified pathologists
- Global accreditations: GLP-compliant and AAALAC-accredited
- Western-standard animal welfare procedures including an independent IACUC committee
- Strict confidentiality and IP data security