Early development phase
Evaluation of your development activities
You have ideas, patents, concepts and a highly motivated team – and want to reach the milestone for the next financing round as quickly and efficiently as possible. It is essential that everything you set in motion complies with the regulatory necessities and at the same time exploits the available regulatory scope. We draw up concepts, verify your documents in terms of regulatory acceptance and advise you together with your project partners.
Early analysis is the key to success
We have a detailed knowledge of the regulatory possibilities – and the regulatory limits. Our goal is to focus your developments on what is necessary and feasible and hence ensure that your products achieve the fastest possible market access. We are quite aware of the different requirements and possibilities for vetarinary and human medicinal products.
Our extensive experience has shown that it is especially important to identify key studies (quality, preclinical, clinical) at the earliest possible stage. This provides the basis for the efficient deployment of limited capital resources and for drawing up a realistic development timetable.
In addition to advising you on new products, generics and high-tech medicinal products, we can also extensively analyse your concepts in the area of advanced therapies. In such cases we also draw on the resources of our Medical Devices Team.
Our services during the early development phase
On your behalf we perform and coordinate the following assignments:
- Feasibility studies
- Development planning
- Milestone definition
- Liaison with the regulatory authorities
- Team meetings
