Pharmacovigilance Excellence
Comprehensive drug safety monitoring and risk management solutions aligned with international standards and guidelines
At Burwood Biotech and Infortech Solution, we are dedicated to ensuring the safety, efficacy, and quality of therapeutic goods worldwide, aligning closely with international standards and guidelines.
Our specialised Pharmacovigilance Services help sponsors, manufacturers, and healthcare providers maintain full compliance with global regulations. We work at the forefront of adverse event reporting, signal detection, risk management, and regulatory submissions, supporting our partners to meet Good Pharmacovigilance Practices (GVP) obligations efficiently and responsibly.
Comprehensive Service Offerings
We provide specialized solutions tailored to your specific needs and challenges
Timely collection, evaluation, and reporting of adverse drug reactions (ADRs) and adverse events (AEs) to regulatory authorities
Development, maintenance, and updates of RMPs tailored to meet global post-market monitoring requirements
Ongoing analysis and proactive communication of product safety signals, aligned with best practice standards
Thorough audit programs to assess compliance with international GVP guidelines and standards
Responding to product safety queries from healthcare professionals and consumers with high-quality services
Expert-led pharmacovigilance training for internal teams on TGA expectations and compliance strategies
Our Pharmacovigilance Approach
A comprehensive methodology to ensure drug safety and TGA regulatory compliance
Assessment
Comprehensive evaluation of your current pharmacovigilance systems and processes
Strategy Development
Creation of tailored pharmacovigilance strategies aligned with TGA requirements
Implementation
Deployment of robust pharmacovigilance systems and processes that meet Australian standards
Monitoring & Reporting
Ongoing safety monitoring, signal detection, and regulatory reporting to the TGA
Continuous Improvement
Regular assessment and enhancement of pharmacovigilance activities to maintain compliance
Why Choose Us?
Global Regulatory Expertise
Deep understanding of international regulatory landscapes.
End-to-End Solutions
From setup to ongoing pharmacovigilance operations.
Risk-Driven Approach
Focused on proactive, lifecycle-based safety management.
Local + Global Knowledge
Integrating regional requirements with international GVP best practices.
We are proud to contribute to public health protection by supporting safer therapeutic goods worldwide.
What Our Clients Say
Burwood Biotech transformed our pharmacovigilance operations, implementing a system that ensures full compliance with TGA requirements while providing valuable safety insights for our product portfolio.
Dr. Michael Chen
Head of Drug Safety, Australian Pharmaceuticals
Enhance Your Pharmacovigilance Operations
Contact our compliance experts to discuss how we can strengthen your drug safety monitoring globally.
Ready to Get Started?
Our team of experts is ready to help you navigate the complex regulatory landscape.
- Expert consultation
- Tailored solutions
- Ongoing support