Quality and precision sets us apart
Commercial Eyes has a reputation for excellence across the range of pharmaceutical commercialisation services we offer. The following accreditations are official third party confirmation of the quality of our work and our ability to deliver strong results for our clients. Our reliable team of experts bring medicines and devices to market in Australia faster for our clients.
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.
Commercial Eyes is the only pharmaceutical professional services provider in Australia/New Zealand to have had a successful audit by the FDA.
TGA Audits
Over the past 18 months, the Medical Services team have participated in four TGA pharmacovigilance audits. There were no major findings against Commercial Eyes noted.
Victorian Poisons and Controlled Substances Licence
Commercial Eyes has a current Victorian Poisons and Controlled Substances Licence. This licence allows Commercial Eyes to handle Schedule 2 (Pharmacy Medicines), Schedule 3 (Pharmacist Only Medicines) and Schedule 4 (Prescription Only Medicines) drugs and coordinate the supply of these products to authorised persons or to those persons holding an appropriate poisons licence/permit when required.
The licence facilitates our Regulatory Services department’s product complaints investigations work and enables our Medical Services team to reference the physical product when responding to medical enquiries from patients and healthcare professionals.
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 major findings against CEPL noted.
We are proud of the quality of the services we provide to our clients and are confident that we stand alone in regard to the scope and quality of pharmaceutical and medical device commercialisation services we offer.
