About US


JOINN LABORATORIES is a leading privately held preclinical CRO founded in 1995. JOINN was GLP certified by SFDA in 2005, accredited by AAALAC in 2008, and inspected by US FDA in July, 2009. JOINN’s headquarters and research facilities in Beijing are housed in a 50,000-square-foot, state-of-the-art facility in full compliance with international GLP regulations. JOINN’s USA office provides direct customer service to western clients. JOINN’s one million square feet new facility near Shanghai (the Heptagon, under construction) is scheduled to start operation in early 2011.
Since GLP certified by SFDA in 2005,JOINN evaluated a total of 235 compounds including 131 biologics, 98 chemicals, and 6 botanicals. We prepare protocols and reports in both Chinese and English. Our study reports submitted in IND packages have been accepted by both Chinese and US FDA to support clinical trials in China and the US.



Non-Clinical Service


Drug Discovery

Pharmacodynamic

Safety Pharmacology

Toxicology

Pharmacokinetics and Toxicokinetics

Pathology Services



Non-Clinical Service

Our Scientific and Regulatory Service Team, with extensive experience in USFDA regulation and western pharmaceutical industry, has forged a unique appreciation of the product-specific complexities of drug development while providing our clients with a comprehensive scientific and regulatory strategy. For each client, JOINN ...

- Designs studies and prepares customized protocols and reports for a spectrum of nonclinical pharmacology and toxicology studies in compliance with both USFDA and FDA regulation.

- Plans and implements strategies, serves as your representative to both SFDA and FDA, and provide application support for IND,NDA, ANDA,or DMF.



Clinical Service

JOINN's Clinical Service Team helps you initiate your clinical trials in support of your IND and NDA filings and marketing approvals. JOINN partners with several accredited domestic clinical trial centers that provide safety assessments and efficacy studies for a spectrum of diseases including HIV. A partial list of our services includes the following:

Protocol Design

CRF Design

Investigators'_ Selection

Investigator’s Brochure Preparation

Trial Organization and Management

Trial Monitoring and Auditing

SAE Reporting

Data Collecting and Analysis

Clinical Report Preparation
 



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