Regulatory support

Regulatory strategy, PMDA consultation (documentation , Q&A, participation)

Support of preclinical and clinical development in Japan

Project management, Japanese liaison

Preclinical development strategy, planning and interpretation of results of preclinical studies,

Clinical development strategy, clinical synopsis, protocol, informed consent, IB, discussion with investigators

Support of in- and out-license and co-development

In-license evaluation, due diligence, Japanese KOL interview, partnership strategy