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OWLPHARMA Consulting
Products
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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Projects
Medical Affairs *
Scientific Communications Development
Strategic Stakeholder Engagement
Defining the Value of Medical Affairs
Evidence Generation
Strategic Communications Planning
Regulatory *
Labeling & Promotions
Maintenance & Renewals
Compliance
Transparency & Disclosure
Commercialization *
Customer Engagement
Brand Planning & Activation
Market Access & Policy *
Government Policy
Global Market Access
Pharmacovigilance *
Safety Systems
Risk Management
Finance & Investment *
Financial Services
Investment Banking
Quality & Mfg *
Facilities & Equipment
Testing & Release
Quality Management
Production & Supply Chain
Clinical Research *
Real World Data Research
Study Operations & Management
Clinical Reporting
Product Development
Trial Design & Planning
Technology & Operations *
Automation & Efficiency
Data & Analytics
Early Development
Digital Health Solutions
Operations
Informatics Infrastructure
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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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