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Pharmacovigilance and Safety Reporting
1
Pharmacovigilance System
Regxia has prepared a compliant system with detailed SOPs, templates and timelines that ensure the safety of your marketed products. Our system has successfully satisfied Health Canada inspectors.
2
Periodic Safety Reports
Regxia’s team can collate, analyze and compile your annual safety reports in PSUR, PBRER or PADER formats.
3
Promotional and Medical Materials Reviews
Our team of experts can objectively evaluate your promotional and medical materials for Canadian regulatory compliance.
4
GVP Self-Inspections
Regxia will prepare your company for Health Canada Inspections by fulfilling your regular self-inspection requirements.
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