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| Overview | Regulatory Strategic Solution | Biopharmaceutical Product CMC | Clinical Trial Service | PET Drugs | Pharmaceutical Product Solutions | Medical Devices & Supplies | ||
| Services: Overview
Pharma Training, Inc. is a developmental consulting company providing strategic solution consulting. Our focus is on clinical trials of biopharmaceuticals, pharmaceutical products, and medical devices (including preclinical studies) in Japan. In addition, we now provide Current GMP consulting for PET drugs based on the updated Japanese investigational drug GMP and FDA guidelines. We consult with hospitals, institutions, and radiopharmaceutical companies to provide a global basis solution for PET drug products. All Pharma Training, Inc. consultants are experts in their field: highly trained scientists experienced in Pharmacology, Toxicology, ADME, CMC, Project Management, Clinical Trials, and Regulatory Affairs of Medical Devices. They have developed new pharmaceutical products and medical devices in major healthcare companies — includng Astellas, Fujisawa, Tanabe, Shionogi, Medtronic, Boehringer Ingelheim, Bayer, Schering, and Eli Lilly — for more than 25 years. We will provide a strategic development plan for each pharmaceutical product or medical device (through class IV, such as vascular stents or cardiac rhythm management devices). Specifically, we consult with clients based on the medical and scientific information (study results and/or an international study plan) and unmet medical needs in Japan to ensure the marketability along with a client's request. We then create a business plan including the regulatory strategy based on the Pharmaceutical Affairs Law of Japan and international standards. Consequently, Pharma Training, Inc. will provide a strategic solution to ensure the speedup and optimization of development of the client's biopharmaceutical or pharmaceutical product or medical device, using all study results obtained from outside of Japan and our own regulatory science. This means that a client can expand their market share with their innovative health care product with a shorter development timeline and reduced costs. Pharma Training, Inc. believes our business contributes to the expansion of Human Health Care in Japan, and the Health Care Industry worldwide. This business is conducted in the Kobe Medical Industry Project Area as well as Tokyo. |
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