Package service for preclinical safety evaluation

We offer an optimal package service for you to achieve your goal, such as IND application and out-licensing

While GLP study items are designated by ICH guidelines, there are various methods to plan the entire preclinical development and preliminary studies. The selection of the study design makes a large difference in the overall study duration and cost.

Here at Axcelead, our safety evaluation researchers, who possess vast experience with drug discovery and reliable technology, propose the most efficient strategy for preclinical development and manage the entire study from study design and execution to interpretation of the result. Furthermore, we offer consulting services for toxicity issues and support for communication with regulatory authorities such as PMDA and FDA.

Total support for preclinical development to achieve your goal

For out-licensing
For IND application

We propose the most appropriate menu for safety studies according to the development status of the compound.

Broad range of support that includes solutions for safety and pharmacokinetic issues and addressing new modalities by experts with knowhow for more than 100 INDs and 20 NDAs/BLAs

We offer comprehensive support for smooth IND application and out-licensing by using our experience with numerous applications in Japan, the EU and the US and knowledge gained through in-licensing investigation!

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