About Hiro Pharma Consulting
Hirotsugu Atsumaru
Pharmaceuticals and Medical Devices Supporting the Future of Global Pharmacovigilance: GxP/CSV Consultation Services
Consulting Service
- Pharmacovigilance Consulting Services for FDA(US) ICH E2B(R3), EMA(EU), MHRA(UK), NMPA(China), MFDS(Korea) and PMDA/MHLW(Japan)
- GxP/CSV Consulting Services for Pharmaceutical & Medical Device in PV System and ERP(SAP S4/HANA) System
Corporate Profile
| Company name | HiroPharmaConsulting® Co., Ltd |
| Establishment | Start of Business: July 1, 2019 Start of Incorporated Business: November 1, 2021 |
| Representative Director | Hirotsugu Atsumaru Class-I Information Technology Engineer (METI) ISPE and PDA Member |
| TEL | 080-5699-3284 |
| Business Description | 1.Providing consulting services to develop RFIs and RFPs for single global safety systems 2.Suggestions to improve safety adverse event case data entry/evaluation and regulatory reporting 3.Provision of safety regulatory information by regulatory authorities in Japan, the United States, Europe, and Asia 4.Providing training sessions on ICH E2B (R2)/(R3) guidelines 5.Support for UAT (User Acceptance Test) scripting and execution 6.Drug Safety Monitoring System Quick Q & A 7.Support for PMDA EDI/GW connection testing (when renewing digital certificates) 8.SAP S4/HANA GxP CSV Consultation |
| Address | 16-12-703, Kikawa-Higashi 2-chome, Yodogawa-ku, Osaka-city, Osaka 532-0012 Japan |
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