Today we present the definition of the #regulatoryintelligence process and its main points of differentiation in relation to the classic #regulatoryaffairs process.
We define regulatory intelligence as:
Regulatory Intelligence is the process of providing strategic information that underpins the making of effective and efficient decisions in relation to the regulatory aspects of the business.
The process covers the following activities:
– Selection of relevant publicly available data sources;
– Collection of this data;
– Analysis of the significance of these data;
– Generation, from the analysis, of significant information for the definition of the regulatory strategy;
– Communication of the implications of this information for the business;
– Continuous monitoring of the regulatory environment, looking for opportunities to model future regulations, policies and legislation.
It is important to understand and recognize the need to separate work fronts, as it is very likely that a substantial part of the time spent by your Regulatory Affairs (RA) team is actually being spent on Regulatory Intelligence (RI), with outputs that are below the needs of your business, in addition to probably not allowing management to explore opportunities.
As recently as in RA, the RI area is very new in Brazil, practically incipient.
From this perception of untapped potential and the impact that RI can cause in the national market, the idea of SQR Consulting arose to launch an innovative service that offers time savings and improved focus on regulatory activities, delivering competitive advantage through information collected, analyzed, synthesized, organized and presented in a systematic way, considering the needs of customers.
#anvisa #produtosparasaude #dispositivosmedicos #saude