Clinical development
Development of medicinal products containing new and known substances
When developing products with new substances you are required to carry out Phase I to Phase III trials of widely differing designs. We will gladly assist you with the planning and realization of these activities. Our focus is on ensuring regulatory compliance. Only if your trials are conducted in conformance with the relevant guidelines (general, class-specific, product-specific) can you assume that regulatory acceptance will be granted.
Products with known substances can also necessitate clinical investigations – e.g. for generics and line extensions. In this area as well, we have a detailed knowledge of the relevant requirements and their currently valid interpretations.
For veterinary medicinal products, we are very familiar with the requirements for Minor Use Minor Species Specifications (MUMS).
From a neutral standpoint we determine and coordinate the necessary steps
We have acquired extensive experience with new product developments (chemical, biological, high-tech) for major international companies and start-up enterprises. Thanks to our contacts with the authorities, we are fully informed about current regulatory requirements and their fulfilment. You can put this know-how to good use. In collaboration with your company (or on your behalf) we determine which clinical activities are necessary for the successful completion of your project. We take care of (almost) everything.
Our services at a glance
On your behalf we perform and coordinate the following assignments:
- Analysis of your product developments
- Feasibility studies
- Development planning
- Development coordination
- Development moderation
- Milestone definition
- Liaison with the regulatory authorities
- Team meetings
