Loading
The RegBlueprint - an innovative web platform for regulatory knowledge management in the pharmaceutical industry
The regulatory requirements that pharmaceutical companies have to fulfil in order to bring medicinal products to market and keep them on the market are constantly increasing.
Thus, recurring tasks in the daily work routine cost more and more time and thus resources. In addition, there is often no way to keep track of the ever-increasing requirements.
Specific software can help to manage the growing complexity of drug registration.
The tools of the RegBlueprint are targeted here and
- speed up recurring tasks,
- provide filtered information,
- simplify the daily routine and save time.
RegBlueprint provides you with the functionalities RegChange and RegFee for your structured marketing authorisation management.
RegChange
The RegChange tool classifies an intended change according to the EU Guideline with just a few clicks. The main content is the so-called "Classification Guideline", which contains the details of the different "categories of variations" based on Commission Regulation (EC) No 1234/2008.RegChange also contains CMDh recommendations on the classification of unforeseen changes ("Article 5", "Z-Variations"). The data model is regularly extended to include these changes.
RegFee
The RegFee tool is a database of regulatory fees (MAA, Variations, Renewals). The tool facilitates the calculation of fees for all types of procedures (national, MRP / DCP, central). The fees are made comparable by establishing a harmonised data model for all states of the European Economic Area (EEA). The expansion of RegFee includes information on veterinary medicinal products and pharmacovigilance in addition to the previous information in the current one.The user can view the list of all agencies in tabular form and, for the sake of clarity, see the associated data (country, documents, fees, comments).
All data of the RegChange and RegFee tool are updated once per quarter.