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RADII (Reg Affairs Data, Information and Intelligence) is a system designed to help manage the reg affairs department of an Australian pharmaceutical company. The system was initially developed in 1996 and has been revised for a number of major pharmaceutical companies even since. This product is about to be upgraded to a web application - it is currently available as an Access of SQL server database

The interface allows users to select a product (brand), formulation then all TGA applications. The next stage is to drill into the Application details, see below


The TGA application screen has a great amount of business logic built into it - for example the self assessable and notifiable fields are disabled for Cat 3 applications, as they are not applicable.

Application fees, Section 31 requests and related document records can be created, of viewed from this screen


RADII can create both DOGFATS and CPD records. It is possible to manage manufacturers including GMP dates. Searches and queries have been written to show all products covered by a given manufacturer or find all products with a given ingredient (active, composition excipient, propietary ingredient etc).


RADII is rich with reports, many customisable. Reports can be added to customise the system to suit each client's requirements

Copyright Bass Data 2007