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