Early testing response at pilot scale! We conduct tests flexibly even in the initial development stage.
Our company conducts BE and PK tests overseas as part of our support for the research and development of generic pharmaceuticals. Under a quality management system based on PMDA guidelines, we provide services that meet the needs of Japanese pharmaceutical companies. The ability to conduct pilot BE/PK tests overseas in a short timeframe and at low cost is a significant advantage, especially for Japanese generic pharmaceutical companies. 【Features】 ■ Responding to the trend of acceptance of overseas test data by PMDA - Appropriate test design is possible based on advanced PMDA materials/policies. ■ Early test response at pilot scale: Flexible testing even in the initial development stage. ■ Competitive pricing compared to Japanese CROs. ■ High-quality data and quick turnaround. - Accelerates decision-making for the next steps without slowing down development speed. ■ Extensive track record of support for Japanese companies: Detailed responses tailored to needs. *For more details, please download the PDF (English version) or feel free to contact us.
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【Recommended for】 ■ Generic pharmaceutical manufacturers (especially domestic companies in Japan) ■ Research and development personnel who want to quickly obtain decision-making materials in the early stages of formulation design ■ Companies that want to conduct BE tests while meeting PMDA requirements and keeping costs and time down *For more details, please download the PDF (English version) or feel free to contact us.
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【Purpose】 ■ Evaluate the effectiveness of formulation design when developing generic pharmaceuticals Used in the early stages (research and development phase) ■ Choose faster and more flexible overseas trials as an alternative to conducting BE tests domestically ■ Utilize for preliminary tests (pilot BE/PK) when early results are desired or to confirm the direction of formulation design *For more details, please download the PDF (English version) or feel free to contact us.
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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.