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Our processes are supported by our well-established ISO accredited quality management framework to ensure process efficiency and optimal outcomes

Quality Management System

Commercial Eyes is committed to total quality management. We have a customer focus and as such are continually improving our processes to ensure the best services and results for our clients. Our critical processes and their interactions are understood and well documented.

The Quality Management System of Commercial Eyes has been audited by Lloyd’s Register Quality Assurance Limited and has been found to meet the requirements of the ISO 9001:2015 QMS Standard. This Quality Standard applies to the provision of consultancy services to the pharmaceutical and medical device industry.

FDA Audit

Commercial Eyes has been audited by the US Food and Drug Administration (FDA) and found to have no written 483 observations. This is an excellent result that confirms Commercial Eyes’ reputation as the foremost pharmacovigilance and medical
information provider in the region.

Client Audits

Medical Services team participated more than 30 client audits requiring thorough oversight of all our processes and procedures. Auditors visited from client headquarters based in EU, USA and Japan. There were no critical findings against Commercial Eyes noted.

TGA Audits

Over the past 18 months, the Medical Services team have participated in 9 TGA Inspections. There were no critical findings against Commercial Eyes noted.