Please leave various tasks related to pharmaceutical development to us.
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.
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【Project Overlook】 ■Evaluation and creation of Common Technical Documents (CTD) ■Products derived from biological sources and regenerative medicine products ■Domestic clinical trial manager ■Face-to-face advice related to clinical trials (clinical trial consultations, simple consultations), response to inquiries after application ■Certification of foreign manufacturers ■Registration ledger for active pharmaceutical ingredients (MF) ■Application for designation of orphan drugs for rare diseases ■GMP compliance investigation ■Various pharmaceutical regulatory documents for Europe, the United States, and Asia ■US Agent ■Legal Representative (LR) ■Qualified Person (QP) *For more details, please download the PDF or feel free to contact us.
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Since our establishment, we have consistently adhered to the principle of "quality first," providing pharmaceutical and biopharmaceutical companies both domestically and internationally with services related to the construction and advice on regulatory strategies and development strategies, including data evaluation for new drugs and biopharmaceuticals in CMC, non-clinical, and clinical stages, as well as face-to-face consultations with PMDA, preparation of marketing authorization applications (CTD creation), and responses to inquiries, contributing to the prompt approval of new drugs. In recent years, we have also been offering development and regulatory-related services for regenerative medicine products. Please feel free to contact us if you have any requests.
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