Genira Pte. Ltd.
Genira Pte. Ltd. provides PV.app, a cloud-based pharmacovigilance platform for AI-powered drug safety reporting. The platform is ICH E2B R3 compliant and supports MedDRA and WHODrug dictionaries.
Listing updated
About Genira Pte. Ltd.
Genira Pte. Ltd. provides PV.app, a cloud-based pharmacovigilance platform for AI-powered drug safety reporting. The platform is ICH E2B R3 compliant and supports MedDRA and WHODrug dictionaries. It enables medical liaisons, doctors, pharmacists, patients and caregivers to send adverse event reports directly to pharmaceutical companies and regulators, with XML, CIOMS and PDF formats generated automatically and an option to send safety reports directly to regulatory electronic gateways.
PV.app is validated in accordance with GAMP5 and is GxP and 21 CFR Part 11 (Annex 11) compliant. It offers redundant cloud storage with audit trail and backups, certified data centers in Asia, Europe and North America, and data processing following GDPR and HIPAA. The platform includes multidevice support, offline reporting, notifications about new ICSRs and AE assessment results, and an embedded hint system.
- Category
- Computer Software & Solutions Provider
- Location
- Singapore
- Website
- pv.app
Summary written with AI from public business data. Disclaimer
Products & services
- PV.app cloud-based pharmacovigilance platform
- AI-powered drug safety and adverse event reporting
- Regulatory electronic gateway submissions
Tap a product to find other suppliers of it.
Location
Quick facts
- Business name
- Genira Pte. Ltd.
- What it supplies
- Genira Pte. Ltd. is listed under Computer Software & Solutions Provider.
- Category
- Computer Software & Solutions Provider
- Location
- Singapore
- Listed products and services
- PV.app cloud-based pharmacovigilance platform, AI-powered drug safety and adverse event reporting, Regulatory electronic gateway submissions. (Summarised with AI from public business data.)
- How to contact
- Phone, website and an enquiry form on this page.
- Listing last updated