For preclinical and clinical requirements we develop science-based strategies that comply with regulatory directives. Trial protocols and study designs for safety / tolerability tests and clinical studies we formulate in close coordination and collaboration with appropriate and verified clinical research organisations (CROs), physician, biometricians and you.

Paediatric application in the Paediatric Investigation Plan (PIP) and the current requirements of benefit assessment we also take into consideration.

An important milestone in your project is accomplished through coordination and monitoring of clinical projects in scientific advice meetings with regulatory authorities.

We offer the following services:

• Approval strategies: analysis of regulatory barriers and options

• Scientific advice meetings with regulatory authorities

• Pre-clinical and clinical expert reports (module 2.4 bis 2.7)

• Consultation of paediatric drugs:

  • PUMA approvals

  • Creation of Paediatric Investigation Plan (PIP), Waiver, Deferral

• Labelling

• Marketing Authorisation application and maintenance

• Processing of the quality part (module 3, module 2.3)

Our project management team assists in the entire process from the development of the strategy, including the Paediatric Investigation Plan (PIP), to the incorporation of the results into the marketing authorisation application.