We will resolve the "impossible" in that drug application. Leave the response to pharmaceutical regulations to us.
Our company supports the introduction of medical devices, active pharmaceutical ingredients, and new food additives into the domestic market through a wide range of services, including drug application services, clinical trials, designated marketing authorization holders (DMAH), MF registration applications, and domestic representative services. Our representatives possess not only scientific knowledge but also high English proficiency and communication skills in their specialized fields. Additionally, we prepare appropriate workflows according to our clients' objectives, providing speedy and high-precision solutions. 【Features】 ■ Services including consulting ■ Support for PMDA consultations ■ Overseas support in English ■ Strict adherence to deadlines ■ Support for safety and quality operations *For more details, please download the PDF or feel free to contact us.
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【Our Strengths】 ■ Exceptional communication skills for information gathering and external support ■ Experienced specialists providing better solutions ■ CRO with manufacturing and sales license *For more details, please download the PDF or feel free to contact us.
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【Concerns in Pharmaceutical Regulatory Applications】 ■ There are multiple application cases, but due to insufficient manpower, the application timelines for some products are being postponed. ■ I have no experience in preparing materials for preparatory meetings or face-to-face consultations with PMDA, so I don't know what to prepare, by when, and how. ■ I cannot accurately convey domestic regulatory requirements to overseas suppliers. ■ I outsourced to a CRO, but the delivery of deliverables often exceeds the deadline. ■ I received inquiries about introducing products from overseas medical device manufacturers to Japan, but since I only have a sales license, I don't know how to proceed. *For more details, please download the PDF or feel free to contact us.
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Our company was founded in 1999 and is a CRO (Contract Research Organization) specialized in regulatory affairs. We support the introduction of medical devices and active pharmaceutical ingredients into the domestic market through a wide range of services, including regulatory submission services, clinical trials, designated marketing authorization holders (DMAH), MF registration applications, and domestic representative services. Please feel free to contact us for inquiries regarding regulatory submissions for medical devices or master file registrations for active ingredients.