Experienced professionals will support you with applications for jointly developed products and introduced products!
Our company has a large number of specialized staff in each part of CMC, non-clinical, and clinical, with experienced personnel in document preparation. The fields we handle are mostly pharmaceuticals (new drugs/generic drugs), but we also broadly support application documents for quasi-drugs, medical devices, pesticides, veterinary drugs, cosmetics, and functional foods. Before delivery, we ensure high-quality deliverables through careful and accurate quality control. Please feel free to consult us if you have any requests. 【Support Content】 ■ Preparation of pharmaceutical approval application documents (CTD M1 M2.7), eCTD conversion ■ Response to inquiries ■ Investigational Drug Brochure (IB) ■ Preparation of Clinical Study Reports (CSR) ■ Preparation of medical device approval application documents, etc. *For more details, please feel free to contact us.
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【Areas of Handling】 ■ Pharmaceuticals (New Drugs/Generic Drugs) ■ Quasi-drugs ■ Veterinary Medicines ■ Medical Devices ■ Pesticides ■ Cosmetics ■ Functional Foods *For more details, please feel free to contact us.
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Our company was established in 2006 as the former Three S Japan before the merger, and since then, we have built a track record as a group of professionals well-versed in non-clinical trials and clinical trials in the development of pharmaceuticals and other products. We have established a support system for a wide range of services in product development, including test design, data analysis and verification, evaluation of related documents, preparation of application documents, and communication with regulatory authorities for pharmaceuticals, medical devices, quasi-drugs, cosmetics, food, pesticides, and chemical substances. Please feel free to consult us if you have any requests.