In the development phase you are focused on the clinical trial results of your product – perhaps you are planning to sell your project at a later stage or to bring a finished product to the market. Either way, we can help you plan your next steps carefully in order to make the right decisions and to develop your project in the most beneficial and secure way.
The client is developing a novel drug for treatment of an orphan condition and seek to mitigate risks before commencing FIH trials.
Seeking Scientific Advice (SA) at a competent authority is increasingly common and provide higher probability of success for the MAA and for the subsequent reimbursement process.
Arex Advisor can give support throughout the full procedure and identify potential regulatory and health technology assessment (HTA) issues. Our consultants will help ensure that the critical questions are raised and that appropriate follow-up measures are taken.
We can assist you preparing the SA package, briefing book and other regulatory documents required in the procedure.
Following a successful SA, our consultants can make sure that appropriate regulatory actions are taken and subsequently help with preparation and submission of the clinical trial application.