A trusted partner for the medicines and medical device industry
Our team is highly quality focused, ensuring patient safety throughout a product’s lifecycle from development phases throughout post-marketing surveillance
Our processes are based on a robust Quality Management System. ISO 9001:2015 accreditation and the integration of industry best practice.
Notably, Commercial Eyes has been inspected by the FDA and the TGA 6 times over the past two years with no critical findings identified. This is an excellent result that confirms Commercial Eyes’ reputation as the foremost pharmacovigilance and medical information provider in the region.
Commercial Eyes has invested significantly into technology, allowing high volume safety processing in-house and fully functional remote working services
Our team is proud to offer Oracle Argus, an industry leading, fully validated E2B (R3) compliant safety database. This enables quality and efficiency in processing, analysing and reporting adverse event cases originating in pre-and-post-market drugs, biologics, vaccine, devices and combination products.
Commercial Eyes can provide rapid set-up of services removing the cost and delay of implementing a compliant pharmacovigilance system in-house.
The pharmacovigilance team can provide a comprehensive service including
Management of local and global PV Systems
Support for clinical trial and post-marketing surveillance
Coverage of all regulatory requirements for pharmacovigilance, device vigilance and consumer
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
Our Pharmacovigilance team provides a comprehensive and ISO accredited service across 20 jurisdictions in Asia-Pacific, Canada, the EU and The United States.
Quality is important to us
Our processes are supported by our well-established ISO accredited quality management framework to ensure process efficiency and optimal outcomes