Medical Devices, In vitro Diagnostics , Complimentary Medicines, OTC and Prescription Medicines at your finger tips.

Strategic regulatory decisions are critical in today’s hypercompetitive environment. Our comprehensive, extensive and up to date Regulatory Information System for all product approvals in Australia, will provide you with relevant, timely and in depth information required for exact and reliable decision making.

Minimise the possibility of a TGA rejection, reduce administrative time delays in reaching the correct decision with regards to correct GMDN codes and product classification. Access other approvals for an improved decision. Determine other manufacturers of similar products. Regulatory Information System has all that information.

 We provide a one month free subscription to our Regulatory Intelligence database for all new TGA approvals. You will receive updated information by email by 9 am every Tuesday of every week for four weeks.

As an example for medical devices, we will include total details for manufacturers and sponsors, risk classifications with related GMDN codes applied by the sponsor and associated wording in the intended purpose used to gain TGA approval. Continual access to the Regulatory Intelligence network is by subscription.

Our services also include extensive reports for all TGA approvals to date such as specific and comparative strategic information for all Kinds of products approved for supply in Australia.

Your latest approval may be considered at the beginning of its product cycle and right now, the competitive landscape has already changed. Planning for continual assessment and counter measures is imperative in ensuring you have a competitive advantage and the provision of improved key values to your customers.

We have the information to meet your objectives and enrich your strategy.

Other expertise: • Consulting on advertising requirements • EU dossier preparation • Document consularisation for the purpose of export • Multi-authority dossier preparation to accommodate Medical Device requirements for several authorities in the Asia Pacific region • Training on regulations and the new EBs System

Let us show you how to start the improved decision making process.