Organisations & Systems
BlueReg has dedicated and experienced consultants who are experts in the field of pharmacovigilance (PV) and quality management.
We are committed to provide the assistance you may need in any of your Pharmacovigilance, RiskManagement and Quality Management activities. We can assist you in the following:
- Advice on the organisation of your PV department
- Setting up your pharmacovigilance system
- Preparation of your Pharmacovigilance System Master File (PSMF), and Safety Data Exchange Agreements (SDEA)
- In-house training on Pharmacovigilance
- Setting-up quality management system (QMS) (management review, quality review, writing standard operating procedures (SOPs), setting up quality indicators)
“All these activities are carried out in full compliance with Good Vigilance Practices, Good Manufacturing Practices and local standards as applicable.”
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