FDA tick of approval: Commercial Eyes’ Drug Safety Group has been successfully audited by the FDA!
A trusted partner for the medicines and medical devices industry
We have developed a comprehensive and ISO accredited service that operates across 20 jurisdictions in Asia-Pacific, Canadian, the EU and the United States. Providing high-quality patient safety & risk management that starts at a product’s development stage and going into post-marketing surveillance.
Our processes are based on a robust Quality Management System, ISO 9001:2015 accreditation and the integration of industry best practice. We have also been inspected by the FDA in 2015 and the TGA 9 times since 2018, with no critical findings identified. We are extremely proud of these results, which continue to confirm our position as the foremost pharmacovigilance and medical information provider in the region.
At Commercial Eyes we understand the importance of progress and have invested heavily into our technological capabilities, to allow for the high volume of safety processing in-house, and fully functional remote working services.
Our distinct solutions for your business include the Oracle Argus Safety Database and a dedicated Patient Safety team.
- Management of local and global PV Systems
- Support for clinical trial and post-marketing surveillance
- Coverage of all vigilance requirements for devices, vaccines and medicines
- End-to-end ISCR management, medical review, signal detection and aggregate reports compilation
- RMP and ASA development
- Preparation of safety database exchange agreements
- Sponsor representation as the health authority contact person and qualified person for pharmacovigilance in AU & NZ
- Inspection readiness activities including implementation of internal and partner PV audits
- Patient Oriented Programs
- Patient Access Program
- Product Familiarisation Program
- Sampling and co-pay programs
- Patient Support Program
- Nurse Support Program
- Allied Support Programs
- Clinical Audits
- Chart Reviews
- Risk management programs
- Collaborative database design, validation and management
- Digital platform
- App development
- Enrolment and registration management
- Inbound/outbound call management
- Notifications management
- Program Administration
- Pharmacy administration
- Reporting metrics and reconciliation
TGA Inspections with no critical findings
Client audits on average per year
Clients where CEPL is the nominated QPPV-A and/or CPPV-NZ