We offer a one-stop system that can consistently handle everything from IND application to CMC dossier creation!
Our company provides comprehensive support for regulatory strategies, including IND applications for pharmaceuticals, CTD/CMC dossier preparation, gap analysis, and bridge study evaluations. We can also assist with the design of First-in-Human (FIH) trials, initial dosing, and PK/PD modeling. Our ability to support everything from Pre-IND strategy design to CMC documentation and compliance with Taiwanese regulations at a lower cost than global CROs is highly attractive for companies aiming for global expansion on a limited budget. 【Features】 ■ One-stop system capable of consistent support from IND applications to CMC dossier preparation ■ Expertise in local regulations, particularly focused on Taiwan ■ High level of specialization in initial dosing and PK/PD modeling ■ Significantly better cost efficiency compared to global CROs ■ Early strategy design at the Pre-IND stage enables shortening of development timelines *For more details, please download the PDF (English version) or feel free to contact us.
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basic information
【Recommended for】 ■ Companies in Japanese pharmaceutical firms or biotech ventures considering expansion into the Taiwanese market ■ Companies lacking resources for CMC, IND, and regulatory document preparation ■ Companies facing challenges in strategic planning and initial design at the Pre-IND stage ■ Development personnel who are concerned about the high costs of global CROs *For more details, please download the PDF (English version) or feel free to contact us.
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【Purpose】 ■ Used for preparing IND applications and CMC documentation when exporting formulations overseas (especially to Taiwan) ■ Support for regulatory compliance and development strategy planning when Japanese companies enter the Taiwanese market ■ A cost-effective alternative to expensive services from global CROs ■ Initial strategy design at the Pre-IND stage (setting initial dosing and PK/PD modeling) *For more details, please download the PDF (English version) or feel free to contact us.
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Company information
Libra Medicina Co., Ltd. aims to contribute to the improvement of health and quality of life for people around the world by being involved in the creation of innovative pharmaceuticals and medical devices through development support services and licensing activities, delivering hope to patients suffering from serious diseases.
