China is predicted to become the world's second largest pharmaceutical market by 2015. Recently there has been a large number of R&D centers set up by major global pharmaceutical companies in China. As a result, more and more animal studies and clinical trials will be led from China. NovoTek can provide knowledge and support to ensure these vital studies are as successful as in their countries of origin. We have extensive experience, having managed large numbers of preclinical animal studies, clinical trials, and regulatory filing in China. We also offer the added benefit of having positive relationships with Chinese regulatory bodies and an understanding of the local county processes as well as global healthcare operations. The key areas NovoTek China can provide support with are detailed below. Please access the relevant area of the site for more detailed information.
Our synthesis laboratory has more than 5,000 sq ft of research lab and 30,000 sq ft of GMP qualified manufacturing space, including four independent function-specific zones: reaction, purification, drying and packaging. This facility is geared towards compound design and the custom synthesis of APIs from milligram to kilogram scale.
State-of-the-art cell culture facility with services including absorption, disposition and metabolism.
30,000 sq ft research laboratory and a 60,000 sq ft of GMP accredited manufacturing facility which provides the capability to carry out a range of pharmaceutical and bioanalytic studies at all stages of the drug development process.
The 60,000 sq ft of animal housing complies with GLP regulation and is capable of conducting pharmacokinetic, pharmacology, and toxicity studies.
Extensive clinical trial experience for both pharmaceuticals and medical devices, and can provide clinical trial study design and execution for all clinical stages.
NovoTek has superior experience on regulatory requirements in China and we understand the numerous difference between Chinese healthcare regulation and those found in the US and Europe. Taking advantage of our knowledge and our case-by-case design of product development and marketing strategies will greatly simplify your entry into China.
State-of-the-art animal facilities with US compliance, fully functional on formulation, bio-analyses, PK studies, pharmacology studies, toxicity studies and data analyses.
Professional team presiding over strictly regulated operations; APIs from our customers are strictly controlled and protected.
Capabilities to carry out studies on mice, rats, rabbits, dogs and primates.