Pharmacovigilance
Ensure the safety and efficacy of your products with our comprehensive pharmacovigilance solutions.
Our team of experienced professionals provides a wide range of pharmacovigilance services tailored to meet your specific needs, including:
- Adverse Event Reporting: Efficient and accurate processing of adverse event reports (AEs) in compliance with global regulations.
- Safety Data Review and Analysis: In-depth analysis of safety data to identify and assess potential risks associated with your products.
- Risk Management: Development and implementation of risk management plans to minimize safety risks and optimize benefit-risk assessment.
- Regulatory Compliance: Ensuring compliance with all relevant pharmacovigilance regulations and guidelines, including TGA, ICH, FDA, EMA, and others.
- Safety Communication: Developing and implementing effective safety communication plans to inform healthcare professionals and patients about product safety issues.
- Global Pharmacovigilance Systems: Establishment and management of global pharmacovigilance systems to monitor product safety worldwide.
- Qualified Person for Pharmacovigilance (QPPV): Provision of qualified QPPV services to oversee your pharmacovigilance activities.
Why choose our pharmacovigilance services?
- Expertise and Experience: Our team of experts has extensive experience in pharmacovigilance and is well-versed in the latest regulatory requirements.
- Tailored Solutions: We work closely with you to develop customized solutions that meet your specific needs and budget.
- Quality and Efficiency: Our efficient processes and advanced technology ensure high-quality pharmacovigilance services.
- Global Reach: We have the capability to support your pharmacovigilance activities in multiple regions worldwide.
Let us help you safeguard the safety of your products and protect public health. Contact us today to learn more about our pharmacovigilance services.
We are committed to the success of your products and to help you develop and implement regulatory and quality solutions catered to your needs.
Our team of consultants bring many years of combined experience in Regulatory Affairs, Compliance and Quality Assurance, working with regulatory bodies around the world such as the TGA, Medsafe, FDA, EU Competent Authorities and Notified Bodies, and various global Authorized Representatives with a proven track record of executing techniques in a timely and cost efficient manner.