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Our company provides consulting services for regulatory strategy and development strategy. Specialized staff in regulatory affairs, CMC, non-clinical, and clinical development support development activities at all stages from early drug development to obtaining approval. Please feel free to contact us if you have any requests. 【Business Overview】 ■ The following services related to drug development: - Planning, evaluation, and advice on regulatory strategy and approval application strategy - Planning, evaluation, and advice on clinical development strategy - Planning, evaluation, and advice on non-clinical development strategy - Planning, evaluation, and advice on physicochemical properties, manufacturing, and quality testing - Preparation, evaluation, and advice on various documents including approval application materials - Planning, evaluation, and advice on negotiations with regulatory authorities in Japan, the US, and Europe, as well as various consultation services, and collection and analysis of regulatory information - Global development planning, evaluation, and advice *For more details, please download the PDF or feel free to contact us.
