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Regulatory Services are:

  • Request for Scientific Advice for the EMA for paediatric use related questions

  • Preparation for Paediatric Investigation Plan (PIP) and Amendments

  • Request for PIP Agreement

  • Applications for a full or partial waiver

  • Applications for deferrals

  • Request for opinion of PDCO for compliance of conduction of the development with the PIP prior submitting an application for marketing authorisation

  • Request for authorisation of conduction of clinical trials at the Competent

  • Agencies and the Ethic Committees

  • Preparation and Submission of Request for PUMA

  • Preparation and Submission of New Drug Applications