ヒロファーマコンサルティング
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ヒロファーマコンサルティング Company Profile
Let's build a strategy for reforming pharmacovigilance operations together with expert consultants!
Our company provides GxP/CSV consultation services related to pharmaceuticals and medical devices that support the future of global pharmacovigilance. We also offer proposals for improving safety adverse event case data entry, evaluation, and regulatory reporting, as well as safety regulatory information from regulatory authorities in Japan, the United States, Europe, and Asia. Additionally, we provide support for the creation and execution of UAT (User Acceptance Testing) scripts.
Business Activities
■ PV: Pharmacovigilance System with AI functionality for GxP compliance: (Patent pending, Application No. 2024-213393) Validation methods as a basic PV CSV method for PV consulting services ■ Provision of consulting services to create RFI and RFP for a single global safety system ■ Proposals for input, evaluation of safety adverse event case data, and improvement of regulatory reporting ■ Provision of safety regulatory information from regulatory authorities in Japan, the United States, Europe, and Asia ■ Offering training sessions on ICH E2B (R2)/(R3) guidelines ■ Support for creating and executing UAT (User Acceptance Testing) scripts ■ Quick Q&A for drug safety monitoring systems ■ Support for PMDA EDI/GW connection testing (during digital certificate renewal) ■ SAP S4/HANA GxP CSV consultation
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Detailed information
| Company name | ヒロファーマコンサルティング |
|---|---|
| Contact address | postalcode 532-0012 Osaka/ Yodogawa-ku, Osaka-shi/ 2-16-12-703 Mukagawa Higashi, 2nd DistrictView on map TEL：080-5699-3284 |
| Industry | Information and Communications |