Insuvia
Insuvia is a leading provider of pharmacovigilance and regulatory affairs services, dedicated to helping the pharmaceutical industry make safe and effective healthcare products available worldwide. With a strong local presence and global reach, Insuvia offers comprehensive support for product development, market approval, and ongoing regulatory compliance across all territories. The company is recognized for its excellence, innovation, and commitment to ethical business practices, and has been listed among Europe's fastest-growing companies for multiple years.
Industries
Nr. of Employees
medium (51-250)
Services
Strategic regulatory planning, dossier writing, marketing authorization applications and lifecycle management with country-specific submission support.
Provision of PV governance (QPPV office, PSMF), local PV personnel, global case processing and regulatory reporting services.
Specialist case processing including intake, triage, coding, medical review, narrative writing, QC, submissions and reconciliation, with focus on complex biotech cases.
Clinical trial safety support including Safety Management Plan development, SAE/SUSAR processing, EudraVigilance responsibilities, medical review and periodic safety reporting.
Setup, GxP validation and migration of safety databases and support for commercial PV platforms, including long-term database management and sponsor profile configuration.
Cross-functional local affiliate services that substitute or enhance regional affiliate functions, providing a single point of contact for local compliance needs across multiple territories.
Strategic regulatory planning, dossier writing, marketing authorization applications and lifecycle management with country-specific submission support.
Provision of PV governance (QPPV office, PSMF), local PV personnel, global case processing and regulatory reporting services.
Specialist case processing including intake, triage, coding, medical review, narrative writing, QC, submissions and reconciliation, with focus on complex biotech cases.
Clinical trial safety support including Safety Management Plan development, SAE/SUSAR processing, EudraVigilance responsibilities, medical review and periodic safety reporting.
Setup, GxP validation and migration of safety databases and support for commercial PV platforms, including long-term database management and sponsor profile configuration.
Cross-functional local affiliate services that substitute or enhance regional affiliate functions, providing a single point of contact for local compliance needs across multiple territories.
Expertise Areas
- Pharmacovigilance and safety management
- Regulatory affairs and submissions
- Local affiliate and country-level regulatory operations
- Clinical trial safety (SUSAR/SAE management and DSURs)
Key Technologies
- Pharmacovigilance safety databases (commercial PV platforms)
- GxP validation for computerized systems
- EudraVigilance reporting
- MedDRA and WHO drug coding
News & Updates
Insuvia listed among the 1000 fastest-growing companies in Europe, ranking 367th in the 2023 Financial Times & Statista list.
Insuvia's Quality Management System was recertified by Bureau Veritas for pharmacovigilance, regulatory affairs, and clinical research services.
Insuvia's Commitment to Excellence
Insuvia emphasizes its commitment to high-quality pharmacovigilance and regulatory services, supporting the pharmaceutical industry worldwide.
Insuvia's quality management system was recertified by Bureau Veritas.
Insuvia ranked 367th in the Financial Times list of Europe's fastest-growing companies.
Insuvia listed among the 1000 fastest-growing companies in Europe, ranking 367th in the 2023 Financial Times & Statista list.
Insuvia's Quality Management System was recertified by Bureau Veritas for pharmacovigilance, regulatory affairs, and clinical research services.
Insuvia's Commitment to Excellence
Insuvia emphasizes its commitment to high-quality pharmacovigilance and regulatory services, supporting the pharmaceutical industry worldwide.
Insuvia's quality management system was recertified by Bureau Veritas.
Insuvia ranked 367th in the Financial Times list of Europe's fastest-growing companies.