Who We Are
We are a CRO providing integrated, scientifically-driven, product development services throughout the drug discovery and development process to enable biopharmaceutical companies to achieve their drug development goals. We have enabled many innovator, generic and consumer health companies of all sizes to file IND, NDA, ANDA, BLA and 505(b)(2) submissions in global markets allowing for successful development of important therapies and products for patients. We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets.
Two Countries, One System
We benefit greatly from having operations in both the United States and China (the two largest markets for CRO services in the world) and are well placed to capture growth opportunities in both markets. Our “Two Countries, One System” approach is integral to our commitment to high quality standards. This approach assures our customers the same quality standards, operating procedures and systems in both China and the United States, whilst also providing our customers with a detailed and highly experienced understanding of the regulations and requirements for drug discovery and development in both countries. This approach enables us to be a partner of choice for companies with multinational requirements or companies that need support for parallel submissions with the US FDA and China FDA.
The Services We Offer
Laboratory Services Supporting Drug Discovery and Development
- Drug Metabolism and Pharmacokinetics (DMPK)
- Safety and Toxicology
- Bioanalytical Services
- Chemistry, Manufacturing and Controls (CMC)
Associated Services Supporting Clinical Studies
The Value We Provide
We are a value-added partner with a focus on solving our customers’ most significant and complex drug discovery and development challenges. Our scientific knowledge base, technical expertise and reputation for high quality services have been integral to our ability to enter into strong long-term strategic relationships and partnerships with our key customers.
- Integrated CRO operating in a large and growing market and well positioned to capitalize on strong industry growth drivers especially in China
- Proven ability to deliver value-add technical expertise because of our deep pool of talented scientist and world-class facilities and equipment
- Stringent quality management systems and strong track record of regulatory inspections
- Proven success in growing our customer base and increasing customer retention
- Strong track record of efficient and integrated delivery differentiated by flexibility when required by our customers
- Highly experienced management team