We accelerate regulatory development of cell and tissue based medicine in Japan through comprehensive development strategy consultation
Comprehensive consultation for pharmaceutical strategic development
We provide advices relevant to product development for cell medicines, based on more than 10 years of experience in drug development, including regenerative medicine and cell/tissue-based drugs and ties with specialists in related industries. We offer the following services as support for enhancing the value of client’s promising drug candidates and formulating efficient development strategies, including investigation of post-marketing profit structures.
Support for Japanese market survey and product licensing-out
- Domestic market size surveys based on the current medical situation of Japan, such as the number of patients, existing treatment options and performance thereof.
- Survey on regulatory requirements, related laws and regulations, social background
- Translation of presentation materials and technical materials into Japanese
- Matching with development companies (licensees) within Japan
- Support for negotiation and communication with Japanese companies
- Interview with specialists, including physicians and researchers in related fields and reporting thereof
Development Strategy Consultation
- Planning of development and application strategy depending on source and characteristics of raw materials, the developmental stage and regulatory requirements
- Investigation of domestic development strategy in line with overseas trial data
- Formulation of plans for necessary additional non-clinical studies and assessment of the results
- From evaluation to improvement of the manufacturing process, support for manufacturing scale changes
- Investigation of product specifications, assessment tests, packaging and containers, etc.
- Translation of English study reports and technical documents into Japanese.
We know the Japanese regulatory environment for cell and tissue based medicines. Our experts look forward to talking with you about your needs and recommended courses of action.