We will help you ensure that regulatory requirements are fulfilled during your product development.
Taking early and sound scientific advice can impact the development significantly, saving time and expenses for any enterprise in any phase of development.
Scientific advice (SA) presents critical feedback from competent authorities for all products, but especially for those under development. Taking SA can be hugely beneficial, even when guidelines on suitable methods and study design already exist.
A successful SA meeting often gives a lead thread on how the development plan can best generate robust evidence for a future marketing authorisation.
Scientific advice is preferable for most pharmaceutical companies, and is particularly helpful for SMEs or academic groups that have limited experience with regulation in pharma.
Arex Advisor can support you with preparing the briefing package, as well as with coordination and support during the actual meeting. We have several consultants with health authority backgrounds who are experienced with the procedure from both a health authority and a company perspective.
Since the SA session is limited in time, the thoroughly prepared briefing package is important to make the most out of it.
Our consultants can guide you with:
-Asking the right questions in the correct way
-Choosing suitable participants
-Choosing the right competent authority
-Rehearsing the meeting and preparing counter-questions and follow-up questions.
Clinical trials support and advice
Medical writing
PIPs
Orphan product support
Erik Hedner
Arex Advisor AB
Contact us
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.