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OWLPHARMA Consulting
Products
Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
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Projects
Clinical Research *
Clinical Reporting
Product Development
Real World Data Research
Study Operations & Management
Trial Design & Planning
Commercialization *
Brand Planning & Activation
Customer Engagement
Finance & Investment *
Financial Services
Investment Banking
Market Access & Policy *
Global Market Access
Government Policy
Medical Affairs *
Defining the Value of Medical Affairs
Evidence Generation
Scientific Communications Development
Strategic Communications Planning
Strategic Stakeholder Engagement
Pharmacovigilance *
Risk Management
Safety Systems
Quality & Mfg *
Facilities & Equipment
Production & Supply Chain
Quality Management
Testing & Release
Regulatory *
Compliance
Labeling & Promotions
Maintenance & Renewals
Transparency & Disclosure
Technology & Operations *
Automation & Efficiency
Data & Analytics
Digital Health Solutions
Early Development
Informatics Infrastructure
Operations
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About
Overview
Guarantees the real-world vigilance of medicinal products, cosmetics, supplements, medical devices and cannabis-based products.
From isolated tasks to assembling the pharmacovigilance system, we guarantee the performance of these services while meeting the growing requirements of the industry.
Pharmacovigilance Systems
- Pharmacovigilance System Master File (PSMF);
- Operating procedures and work instructions;
- Maintenance of the quality management system that supports PhV activities.
Pharmacovigilance Activities
- Local and international literature monitoring;
- Adverse events and reactions management;
- PSUR & RMP elaboration;
- Medical review of adverse reactions;
- EudraVigilance monitoring;
- Signal Management;
- PhV training.
Qualified Person Responsible for Pharmacovigilance
- EU QPPV & Deputy;
- Local QPPV;
- Medical support.
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