Product Registrations:

Our preliminary meeting will form the basis of the regulatory strategy moving forward. We are most flexible with the initial discussions either by phone conference, at your facility or at our premises.

We will share with you the regulatory landscape for similar products in Australia and will work with you on the most strategic tactical approach for a timely product approval.

We will give you the choice to either ask the right questions to your manufacturer with regards to key product information required for the Australian submission or you can leave it to us for total coordination.

You will be given accessibility to our secure website portal for live and up to date project updates.

Our differentiated approach will allow you to download information directly to the secure and company specific portal for our assessment and feedback. Our e-document system will allow you to retrieve information at most times at a click of one button.

Auto monthly reports to your management format can be produced and auto sent to you pursuant to your requirements.

Accessibility at your fingers when you want it….

Quality Compliance:

RQSolutions considers that whether you are a startup company wanting to set up a Quality Management System or an already established Manufacturing facility wishing to carry out a pre-audit inspection or companies wanting to assess a third party supplier or manufacturer, our tenets of experts with assist you with this service.

Our experience includes auditing work pursuant to ISO13485, ISO9001, MDD 93/42/EEC with world renown notified bodies use e document paperless audit assessments with findings and recommendations shared and submitted at the exit audit meeting.

We use a 2 pronged approach in Quality Management and consider both to be equally important. These are compliance to requirements and suggestive process improvements.

Let us show you how…..

Regulatory Intelligence:

RQSolutions have developed Information retrieval capabilities in Medical Devices, Complimentary Medicines, In Vitro Diagnostics, OTC and Prescription Medicines.

Our Regulatory Intelligence System has accessibility to a myriad of data that can put you at a competitor advantage.

We can also implement an Internal Registration Management System for Medical devices that puts you in control of your own document records.

The system known as Registration Master has being put into practice in a number of companies.
Let us show you how…