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07.regulatory

Regulatory/Regulatory Affairs

07

We accompany you throughout your research projects

1

Types of services we offer during the drug life cycle:

  • Start-up Studies:
    • Analysis of requirements and drafting of documentation necessary for presentation at the CEIm
    • Protocol design
    • Procedure and presentation
    • Contract management
    • Response to allegations to obtain a favorable opinion
  • Monitoring and Analysis of Study Results:
    • Design and implementation of electronic CRD
    • Monitoring patient recruitment and resolution of queries
    • Writing interim reports, final report and Clinical Study Report
  • Drug positioning:
    • Value dossiers
    • Critical analysis of IPT and advice for drafting allegations
2

Types of Studies we work on:

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

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