regulanet® is a network of independent regulatory affairs consultancies with representation in over 90 countries throughout the world.
|Type||Public / Private|
Founded in 2001 by Dr. Regenold GmbH, regulanet® offers services to a wide variety of national and international healthcare and pharmaceutical clients.
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
•Medicines •Biopharmaceuticals •Orphan Drugs •Medical Devices •In Vitro Diagnostics •Combination Products •Companion Diagnostics •Borderline Products •Herbal & Traditional Herbal Medicines •Food Supplements •Cosmetics •Chemicals