Automated Regulatory Intelligence Service
Solution description
ProductLife Group’s innovative regulatory intelligence automation solution was designed to create, implement, and validate a set of company-wide processes for periodic searches, and deliver them in an easy-to-use, readable, and tailored format.
Initially the solution was developed to help a client quickly perform a 14-step structured process aimed at checking, collecting, verifying, and analyzing relevant data from institutional regulatory databases for their large generic portfolio and their corresponding originator products. These activities are repetitive, time consuming, and prone to errors and have to be carried out in a short period of time. In addition, the results of each search have to be converted into a tailored format and archived according to client needs — another time-consuming and error-prone task if done manually.
In this example, automated searches are based on a complex database/tracker updated periodically following instructions from the client. The findings are used to check he institutional websites to determine whether there have been any changes in the product information of the original products in order to update the client’s generic product portfolio.
After the check and the identification of the updated products, the changed files are downloaded, formatted, and compared with the client’s equivalent files. The documents, detailing all changes between the new and the old version, are filed in specific folders for every product and change. Finally, the documents are reviewed by PLG’s subject matter experts for regulatory review and sent to the client.
The tool supports client needs across the life sciences and can be leveraged to create, implement, and validate company processes to automate periodic searches for different client needs.
Method & tool
The approach used in developing this structure is based on Robotic Process Automation and could also be used as input for a machine learning/natural language processing system.
Tools are validated comparing results obtained automatically vs. manual searches. Documentation of results is prepared for archival or auditing purposes.
The system in place is based on the open-source programming R and visual basic application (VBA) environments.