Pharmacovigilance
We monitor your products performance post market, manage recalls and adverse event reporting, and ensure continued compliance.
Medical device safety doesn’t stop after approval. Ongoing vigilance is critical to maintaining compliance and ensuring patient safety. ANZ Reg Consultants offers a comprehensive range of device vigilance services, including…
- Adverse Event Reporting: Ensure swift and compliant handling of device-related incidents.
- Post-Market Surveillance: Monitor your device’s safety and performance over its lifecycle.
- Regulatory Updates: Stay informed and compliant with the evolving post market vigilance requirements under the proposed Medical Products Bill.
As a Qualified Persons (QP) for Pharmacovigilance (PV), we serve as your dedicated local contact for Medsafe, ensuring clear communication and full compliance with safety requirements. This role guarantees that any adverse events (AEs) or adverse drug reactions (ADRs) are reported promptly and accurately in line with Medsafe obligations, supported by a strong system for monitoring and reviewing safety data.
At ANZ Reg Consultants, we place patient safety at the core of our services by delivering comprehensive pharmacovigilance support. Acting as your QP and local representative, we provide:
- Adverse Event (AE) and Adverse Drug Reaction (ADR) Reporting: Timely, precise submissions in accordance with Medsafe standards.
- Safety Data Oversight: A robust framework for capturing, evaluating, and managing safety-related information.
- Risk Management Planning: Proactive development of strategies to detect and reduce potential risks.
Protect both your patients and your business with our dependable pharmacovigilance expertise.