RQSolutions is a team of strategic professionals with over 35 years in Product Registrations and Quality Management in the Health Care Industry.
We are well known at both a local and global level with involvements with a number of companies ranging from the startup company to multinational manufacturing facilities in Europe, US and the Asia Pacific region.
Our forte is our continual training on updated regulatory requirements, our deliberations in various committees in association with our collaborating partners for a globalised and harmonized registration framework and the implementation of best practice excellence in Quality System maintenance.
We work closely with the Therapeutic Goods Administration (commonly referred to as the TGA), the Australian government regulatory health authority, responsible for therapeutic goods clearance for our client companies intending to supply therapeutic products – Medical Devices
Products approved for supply to the Australian Healthcare market include orthopaedic implants, pacemakers, ophthalmic, surgical equipment and a myriad of other medical devices with a risk classification of I to class III and AIMD).
We are continuously looking at partnership with other associations in our effort to jointly provide excellence in the services we provide.
We also represent OBELIS. S.A. in Australia for companies who are looking for EC representation and product registrations in the European market. Click here to visit our page at OBELIS. S. A. Click here to visit the OBELIS. S. A. page on the Australian and the European Regulatory Environment for Medical Devices
Should you require to contact them, Please email Obelis on email@example.com or call RQSolutions directly on +61 2 9882 2030 and ask for George Azoury.
The regulatory and approval pathway is challenging, cumbersome and is filled with setback and disappointments. Partnering with professional who know the landscape, rules and regulations Mike Neilon, Vice President,International- Glaukos Corporation – USA
RQSolutions has provided the Regulatory Service for the Kaz product BP6200 . During the project my experience with George was very positive. He is a Eric Lam, Manager, Regulatory Affairs & Factory Audit – KAZ – Hong Kong
I have utilised the services of George Azoury and RQSolutions on a number of occasions. Projects have included TGA registrations, as well processing applications for Anthony Anderson, General Manager – Signature Spine – Australia
I have personally worked with RQSolutions and in particular with George Azoury, for the past several years. From the first time of being introduced to Martin Chambers ,VP Global Sales -Spinal Modulation – USA
I had an urgent requirement to ascertain the Australia situation regarding a range of TGA product licenses. George clearly was very knowledgeable on all the Tony Pansabene, Managing Director – Ultra Business Solutions – USA
Our company used George as a consultant to perform registration of our medical devices in Australia. George managed the process from start to finish, and Dave Fernquist, VP Regulatory Affairs – Glaukos Corporation – USA
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