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.

CASE

Scientific Advice preparation and assistance

Client need

The client is developing a novel drug for treatment of an orphan condition and seek to mitigate risks before commencing FIH trials.

Our solution

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.

CASE

Technology Transfer support

Client need

To better utilize manufacturing capabilities, the client plans to outsource a product to a CMO. Changes in the manufacturing process will be necessary in the transfer.

Our solution

Initially, our experienced consultants will perform gap analyses to evaluate impact of changes in the manufacturing process as well as identifying regulatory risks.

 

Arex Advisor will map regulatory requirements and set up timelines and deadlines in close collaboration with the client. Our consultants will form an integral part of the client project management team and ensure that regulatory requirements are met.

 

Experts in CMC and GMP will work closely with the client to minimize impact on product quality and assure consistency throughout the manufacturing process.

CASE

Market landscape review

Client need

To prepare the positioning of their new treatment in the therapeutic market, while competitors are also currently under development or already entering the market.

Our solution

To prepare for a successful launch in several European markets, understanding the market access situation is of high importance. Our team offers support in performing a market access landscape review. The first step of the project is to align which geographic markets and analogues are of interest to the company, hereafter data is gathered and reviewed including but not limited to, unmet need, clinical guidelines, competitors trial information and previously published health technology assessment (HTA) reports.

 

This type of project is valuable in several areas of market access. Insights of a landscape assessment are of interest in identifying key hurdles and opportunities in both clinical and economic evidence. Our team can provide strategic recommendations for evidence generation needed for HTA submissions or early HTA scientific advice engagements. In addition, gathered insights are of relevance in developing new or support existing payer value messaging/proposition and global value dossiers.