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Regulatory Affairs


Support for your research projects throughout the drug life cycle:


Types of services we offer during the drug life cycle:

  • Study start-up:
    • Analysis of requirements and drafting of documents necessary for presentation to the Research Ethics Committee for medicinal products
    • Protocol design
    • Submission and presentation
    • Contract management
    • Response to ethics committee queries
  • Monitoring and analysis of study results:
    • Design and implementation of electronic CRF
    • Monitoring of patient recruitment and resolution of queries
    • Drafting of interim reports, final report and clinical study report
  • Positioning of the drug:
    • Value dossiers
    • Critical analysis of therapeutic positioning report (TPR) and advice on the drafting of allegations

Types of studies on which we work:

  • Clinical trials
  • Observational studies
  • Validation of Medical Devices and Companion Diagnostics

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    Plan de Recuperación, Transformación y Resiliencia - Financiado por la Unión Europea - NextGenerationEU
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