Project Description
The importance of Regulatory Intelligence for your companies
Regulatory Intelligence is a resource that provides strategic information when making efficient decisions in the regulatory context. It is one of the most important visions for your company that needs to comply with government requirements.
An effective regulatory process uses data intelligence to monitor and integrate information, then conduct an in-depth investigation of the product in question. In this view, it is so significant the choice of Regulatory Intelligence when regulating your company.
In the field of regulatory affairs, it is extremely necessary to have qualified professionals to work in Regulatory Intelligence, providing a strategic structure to the other sectors of the company, acting as a systematized sector and having in-depth knowledge about the nature of your company.
Passarini Group is a company that has the best specialists in Regulatory Consulting for Medical Products, applying the One Stop Shop concept daily in your company with practical solutions.
The process covers the following services offered:
- Monitoring of mentions of the client and competitors (if the client requests, up to 3 competitors) in the Federal Official Gazette (Section 1 – NORMATIVE ACTIONS and Section 3 – CONTRACTS, ANNOUNCEMENTS AND NOTICES): mentions of deferrals, denials and others;
- Verification of messages in the client’s Mailbox – ANVISA;
- Verification of techno-surveillance notifications – Notivisa – ANVISA;
- Verification of news on the ANVISA website of interest to clients.
The service will take into account the General Data Protection Regulation – GDPR and Confidentiality of information
What activities are related to Regulatory Intelligence?
Passarini Group can assist your company in strategies to comply with government requirements:
- Monitoring of mentions of the client in the Federal Official Gazette:
– Client: sent on the same day;
– Competitors: if the client requests, up to 3 competitors – sent on the monthly newsletter. - Monitoring of publication of new legislations of interest to client.
- Verification of messages in client’s Mailbox: warning that there is an unread message – sent on the day the message is identified (do not open the message);
- Verification of techno-surveillance notifications – Notivisa: warning that there are open Notifications – sent on the day the message is identified (do not open the message);
- Verification of news on the ANVISA website of interest to Passarini and/or client.
- Updates on new legislations and/or news of interest to client;
- Communication of the existence of messages in the client’s Mailbox;
- Communication of the existence of techno-surveillance notifications – Notivisa;
- Mentions in the Official Gazette of the client and competitors.
All right to start your Regulatory Intelligence?
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