Freelance CRA, Regulatory & Project Management Services in Spain

Regulatory Affairs services:



  • Submissions in CTIS (Part I and Part II)
  • Local submissions in Spain (CA and EC) [non-CTIS]
  • Medical Devices (including IVD) submissions
  • Submissions to the MoH for the exportation of biological samples
  • Regulatory Manager able to coordinate submission in all EU countries


CRA services:


As a freelance CRA, services include activities from the start (feasibility) until the end (close-out visits) of the project.  Also isolated tasks can be performed:

  • Site Selection and feasibility
  • Input on investigator’s selection and Key Opinion Leaders (KOL)
  • Pre-study/site selection visits
  • Ethics Committee and Regulatory submissions
  • Budget and contract negotiations
  • Import license / Export license for biological samples
  • Monitoring
  • Sites close-out visits
  • Inspection and/or audit preparation

Project Management services

Other Services:

  • Recruitment specialist
  • Translations
  • Medical writing
  • Liason with local vendors (drug storage facilities, central laboratories in Spain, local medical providers, etc…)