NEW APPLICATION:

regulatory activity starts with the submission of the product to the Authorities in order to obtain the product license. It is of the outmost importance to keep a record of dates that would allow the user to program the launch and the start of commercialization. In this way, the Software in Regulatory Affairs files all the dates related the product license, such as date of submission, date of approval and expiry date.

INFORMATION ON REGULATORY AFFAIRS:

The software archives and displays the most important characteristics for every product in Regulatory Affairs, allowing for the immediate identification of every record registered by the laboratory.

UPDATES OR CHANGES POST-APPROVAL:

After the approval, the product license should be updated with all those changes that allow the product to adapt to evolving markets that demand consumer satisfaction.

RENEWALS:

The submission cycle includes the processes of renewal for the product license.

The software comes with a system of early alerts for the license expiry date so that it is possible to program the information application and the submission of the dossier on time; making sure that the product will be on the market in a timely manner.

The history of the archived license in the software will allow the user to renew the license accurately, preventing the user from receiving warnings by the regulatory authorities. AffariSoft allows the user to include all kinds of comments through the historical archive of observations and attach all related documents generated by the Regulatory Affairs Agencies throughout the life cycle of the process.