TGA Inspections are Coming – Is your Company Ready?
The TGA has recently concluded its pilot program in Pharmacovigilance inspections in…
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.
TGA Inspections with no critical findings
Client audits on average per year
Clients where CEPL is the nominated QPPV-A and/or CPPV-NZ