PHARMACOVIGILANCE
Seed Pharma specializes in providing comprehensive pharmacovigilance (PV) services to ensure compliance with Therapeutic Goods Administration (TGA) regulations in Australia. Our team is highly qualified and experienced in the following areas:
- Australian Pharmacovigilance Contact Person
Primary point of contact for all pharmacovigilance activities within Australia, ensuring seamless communication and compliance.
Qualified Person for Pharmacovigilance (A-QPPV) Services
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- Providing a Qualified Person for Pharmacovigilance (QPPV) who actively oversees pharmacovigilance activities to ensure regulatory compliance.
- Submitting Serious Adverse Reaction Reports to TGA
- Timely and accurate reporting of serious adverse reactions as required by TGA regulations.
- Notifying Significant Safety Issues to TGA
- Immediate notification of any significant safety issues related to pharmaceutical products.
- Managing Safety Data Exchange Agreements
- Establishing and maintaining safety data exchange agreements with partners to ensure seamless communication and compliance.
- Literature Search
- Conducting thorough literature searches to identify and assess safety information pertinent to pharmaceutical products supporting proactive risk assessment.
- Updating Product Labels and Product Information
- Regularly updating product labels and information leaflets with new safety data to ensure ongoing compliance and patient safety.
- Risk Management Plan (RMP) and Additional Safety Activities (ASA) Development
- Creating and maintaining comprehensive Risk Management Plans and Additional Safety Activities to mitigate potential risks.
- Managing Quality complains
- Managing Product Recalls
Contact Seed Pharma today to discover how our tailored pharmacovigilance services can support your regulatory compliance and patient safety objectives effectively.
