If you enlist the support of Arex Advisor with Regulatory Intelligence, we will make sure you are aware of legislative changes in good time. This will put you in prime position to take strategic decisions, find resources and plan the actions to adapt to the change – while prioritising such core components as compliance, transparency and patient safety.
Local Regulatory Intelligence is the process of gathering and analysing publicly available information on regulatory requirements, communicating them in a clear and actionable way, and providing advice on how to best take these requirements into consideration.
Monitoring for changes in the regulatory environment is a matter of experience and a strong focus on detail, as well as change management.
We have an experienced team of regulatory affairs professionals who can help you with Regulatory Intelligence both to assess a specific update (i.e. when you need to monitor and assess a procedural change for compliance) and on an ongoing, long-term basis.
Some of our experts have pharmacovigilance as their area of focus, creating the synergy that is needed for thorough and safety-focused regulatory intelligence activity.
Lifecycle management
Regulatory project management
Ethical review of promotion materials
Product information services
Lovisa Rosenquist
Arex Advisor AB
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Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.