Over a million new chemical compounds are discovered each year in the world for potential drug products. Of these compounds, only one in ten thousand (some say one in a hundred thousand) makes it to the market, and its development requires at least ten years. R-Tech Ueno boasts a unique technological strength at every stage of the development of new drugs.

Discovery:

In order to discover an effective compound and optimize it, screening is carried out with various animal disease models and the compound's mechanism of action is explored.

Pre-clinical Research:

We carry out comprehensive drug safety evaluations, including safety studies using animals and cultured cells, measurements of in vivo drug concentrations using microanalysis technology and the elucidation of metabolic pathways using radioactive isotopes. In the CMC (Chemical, Manufacturing and Controls) area, we perform studies on synthesis process control, properties evaluations, and absorption and stability studies for superior drug formulations.

Clinical Research:

We manufacture drug samples to be used in clinical trials domestically, but also to be distributed in the United States and Europe.

R-Tech Ueno's Drug Sample Techniques

• Compliance with the GMP
• A production configuration catering to the stages of development from small scale projects to commercial production
• Multiple product manufacturing capability
• Various forms of drug administration (oral, injection, eye drops, ointment, etc.)
• Production of clinical samples with radioactive tags

Approval:

In the field of Regulatory Science, R-Tech boasts a fruitful record of experience. Our company has had extensive experiences in the NDA and sample drug approval process with the Japanese Ministry of Health, Labor and Welfare, as well as with the American Food and Drug Administration and the European Commission (EU).