Strategy & Regulatory Roadmaps
This overarching consulting service is relevant on one hand, for companies which are not confident of the best strategy for the development, commercialization, and reimbursement of their product in the European market, or unfamiliar with local regulations and market conditions. On the other hand, it is also extremely useful for established companies, which are experiencing issues such as slow recruitment rates for their studies or a delayed regulatory approval process (please also see section MDKeys). Our senior advisors, whose skills span clinical development, operational management, and HEOR, work together to answer questions such as:
- Which countries are optimal for conducting your clinical study based on regulatory process and the relevant conditions (routine practice, comparators, technology) for testing your product?
- Does the protocol meet all relevant regulatory requirements? Does its design guarantee obtaining all necessary data for your product strategy?
- What are the best strategies for optimizing recruitment for your study?
- What risk management actions can be taken to avoid delays and going over budget?
- How can you obtain the most precise medico-economic data to achieve reimbursement of your product in major European markets?
Our commitment is to work with you as one team, sharing our know-how on the EU regulatory and reimbursement landscape to guarantee the fastest possible results for your end goal with minimal risk. We will always alert you to some vital considerations at the beginning of our collaboration on any project but an in-depth strategic consultancy service is recommended in less straightforward cases.