Our Services
Services for Product Licensing from Japan
1. Supports in Due Diligence at Japanese Licensor Company.
2. English Technical Translation of Japanese Study Reports and internal documents.
3. Assistances in the Technical Negotiations and Communications with the Japanese Licensor company.
Services for R&D in Japan on Products Discovered Outside Japan
1. Development Planning in Japan based on Japanese Regulatory Requirements.
2. Translation of English Study Reports and technical documents into Japanese.
3. Preparation of Submission and Notification for Regulatory Submission.
* Clinical Trial Notification, New Drug Application, Master File, Foreign Manufacturer Accreditation, etc.
Services as Your Liaison Office in Japan
1. Prepare, submit and maintain DMF and Foreign Manufacturer Accreditation in Japan on behalf of the non-Japanese Clients.
2. Obtain Summary Basis of Approval, Package Inserts, and other product information which is publicly available only in Japanese.
3. Negotiate and Communicate with Japanese companies on behalf of the clients.
4. Perform sponsor audit for clinical sites, vendor audit at manufacturing sites, and any other on-site inspection on behalf of the clients.
Regulatory and Medical Status Research
1. Approval Status of Medical Products, Competitors, Market Size, Price, Pharmacovigilance, and etc.
2. Interview Medical Professionals and Academic Experts.
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