Title | Pharmacovigilance Services in Australia by DDReg Pharma |
URL | https://www.ddregpharma.com/pharmacovigilance-services-in-australia |
Category | Business --> Healthcare |
Meta Keywords | Pharmacovigilance Services in Australia ,Pharmacovigilance Services |
Meta Description | Pharmacovigilance Services in Australia ensure drug safety, monitoring adverse effects post-market, while Regulatory Services in Australia govern the authorization and compliance of therapeutic goods, upholding healthcare standards. |
Owner | DDReg Pharma |
Description |
DDReg Pharma offers comprehensive pharmacovigilance services in Australia, ensuring drug safety and regulatory compliance. Our expert team supports pharmaceutical companies with:
ICSR Processing & Submission: Efficient triage and submission of Individual Case Safety Reports (ICSRs) and SUSARs using E2B(R3) compliant systems.
Signal Management: Proactive identification and evaluation of safety signals to inform risk mitigation strategies.
Risk Management Plans (RMPs): Development and maintenance of tailored RMPs, including REMS, to address safety concerns.
Aggregate Reports: Preparation of PSURs, PBRERs, DSURs, and ASRs to meet regulatory requirements.
QPPV Services: Provision of Qualified Person for Pharmacovigilance (QPPV) services, including oversight and compliance monitoring.
Partner with DDReg Pharma to ensure the safety and compliance of your pharmaceutical products in the Australian market.
For more information, visit our Pharmacovigilance Services in Australia page. |