Product and portfolio analysis

Lean development and rapid market access

We keep your development processes lean and efficient. At an early stage we analyse your development projects and potential licensing arrangements. In this way you avoid unpleasant surprises when moving into new markets.

Our services

To guarantee lean development we review your documents and planned trials to ensure that they conform to the relevant scientific, technical and formal requirements of the regulatory authorities. A detailed knowledge of the numerous directives and consensus standards is a prerequisite for achieving early regulatory compliance and rapid market access for your products.

Is acceptance of your data guaranteed?

Our employees have gained experience with a wide variety of product groups and have successfully completed a very large number of marketing authorisations in all the EU member states. For this reason we can accurately assess the acceptance prospects of your product documentations. This also applies to products that are already on sale in individual countries and are now to be launched in new markets and/or to products that you want to develop further.

A selection of our due diligence activities:

• Screening and evaluation of non-confidential data
• Evaluation of confidential documents
• Weak-point analyses and proposal of solutions