Drug Metabolism and Pharmacokinetics (DMPK) Service
- The highly trained and experienced scientific team provides broad and in-depth expertise/advice to clients on appropriate study designs, execution of studies, and interpretation of the data.
- For pharmaceuticals, we conduct a range of in vivo and in vitro ADME studies that are needed for selecting lead drug candidates in discovery or are required for regulatory filings of potential therapeutic agents.
Toxicology Services to Guide New Therapies from Discovery to Full Development
- Our extensive profile of IND enabling pivotal studies support swift progression of your lead compounds into the clinic – streamlining your development process. We provide the resources of a highly skilled, client-focused staff with extensive academic, scientific and pharmaceutical industry experience.
- The toxicology business unit provides an array of services for investigational purposes, or IND, support. And our GLP toxicology studies have supported hundreds of successful client IND submissions.
Bioanalytical Services to Help the Molecule to the Market
*As of Q1 2020
- Over 280 scientists in 4 facilities with 15 years of Bioanalytical expertise located in the USA and China.
- The experienced bioanalytical scientists support a full suite of services using state-of-the-art instrumentation.
- Our experience and performance metrics translate into the highest quality, reproducible bioanalytical data. The bioanalytical laboratories are compliant with internal standard operating procedures (SOP), Good Laboratory Practice (GLP) and world health authority guidance.
CMC (Chemistry, Manufacturing, and Control) Services to Support Formulation to the Pharmacy
- The CMC team operates under strict adherence to ICH and US FDA GMP guidelines.
- Our broad portfolio of CMC services spans drug product development, analysis, and clinical trial materials’ delivery and supply.
- The formulation development and CTM manufacturing team designs formulations for targeted delivery of a therapeutic and then develops GMP manufacturing processes to ensure a high quality product is produced for clinical trials.
Bioequivalence Studies to Support for International Customers Seeking to Make Applications for Approval in the United States
*As of Q1 2020
- Familiar with the applicable regulations and relevant industry standards required and expected by our customers for standard medical documentation, including consent forms, periodic safety reports, protocols and abstracts.
- Perform studies that track and manage adverse effects of drugs that have already received regulatory approval and may have been released onto the market.
- In compliance with Chinese law, our clinical trial services conducted on patients are done in collaboration with 18 hospitals.
- Experience with a number of drugs and variety of indications such as cancer, infectious disease and central nervous system disease.