Therapeutic Goods Registration & Administration

Every manufacturer, sponsor and potentially, distributor of Therapeutic Goods needs to get his products registered pursuant to requirements applied by the relevant Health Authorities.

Requirements may be different for different countries but some of the basic elements are essentially similar, in particular where compliance to International Standards is a gazetted order through legislation.

In order to stay at a competitive advantage, you should take advantage of the assistance provided by Therapeutic Goods Registration & Administrations service providers.

It is obvious to stay that well prepared and substantiated documentation plays a major part in a successful assessment.

Most businesses, unfortunately, face problems in this area and at most times, this lack of expertise results in the rejection of the application. A costly exercise from the aspect of paid fees and as importantly the time spent in the compilation process.

It just makes strategic sense to ask for assistance from regulatory experts who have a long history with working in the pertinent legislative environment. It is as important to consider working with companies that have the right pulse in any regulatory updates. A simple phone call or that initial email to discuss the services provided is one of the best ways to scrutinize the provider’s capabilities.

A well established and recognized Therapeutic Goods Registration & Administration service provider will give you that Quality Assurance that the complete project related process from technical file compilation through to negotiation with the Regulatory Authority achieves the intended scope of the project.

The Therapeutic good Registration and Administration service should assist you in:

• Ensuring that all your documentation comply to the necessary quality, safety and regulatory requirements

• Ensuring that your products meet proposed claims and

• Provide advice on available options towards improving the effectiveness of your internal infrastructure and deliverables to your customers

A consulting company providing you with a service should also have the following capabilities:

1. Assess upfront and the onset of the initial discussion, the Registration requirements for your products and devices

2. Assist in the determination of the GMDN codes for your devices and Goods.

3. Conduct a technical file review within an agreed timeline to see that your file is complete.

4. Assist you in compiling and reviewing the clinical summary of your Goods.

5. File documentation on your behalf

6. Negotiate with the concerned authorities on your behalf

7. Complete all other regulatory requirements for your products

An organization does not have to be concerned with any of the various details related to required documentation and Registration processes as these are handled by experts with years of experience in compiling numerous technical files. This experience and expertise will ensure a timely assessment and approval of your product.