Regulanet®
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regulanet® is a network of independent regulatory affairs consultancies with representation in over 90 countries throughout the world.
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Type | Public / Private |
Contents
[hide]History[edit | edit source]
Founded in 2001 by Dr. Regenold GmbH, regulanet® offers services to a wide variety of national and international healthcare and pharmaceutical clients.
Pharmacovigilance[edit | edit source]
Our pharmacovigilance team helps you manage and monitor all safety aspects of your product or device so that it meets the required regulations. Our services include:
- An EEA-qualified pharmacovigilance specialist
- Pharmacovigilance quality system preparation and management
- Good pharmacovigilance practice auditing
- Post-marketing case processing management, including EudraVigilance reporting
- Signal detection
- Local and global literature reviews
- Safety database management
- Periodic safety update report preparation
- Risk management plan preparation
- Clinical trial pharmacovigilance services, including preparation of development safety update reports and case processing
- Pre- and post-marketing pharmacovigilance project management
Product Expertise[edit | edit source]
•Medicines •Biopharmaceuticals •Orphan Drugs •Medical Devices •In Vitro Diagnostics •Combination Products •Companion Diagnostics •Borderline Products •Herbal & Traditional Herbal Medicines •Food Supplements •Cosmetics •Chemicals