Services / Regulatory Affairs

Regulatory Affairs


Study start-up process is aknowledged to be critical to the successful management of clinical trials and observational studies.

During the start-up phase, it is essential to have and mantain an internal database where requirements, model forms and key contacts are kept both secure and with easy access for review and update.

In addition, it is important to have readily available clinical study agreement templates , which are very important in order to reduce the time of this phase of the research.

Our company have successfully launched over 800 observational studies and 200 clinical trials over the last 10 years.

Regulatory affairs services include:

  • Preparation and gathering of essential documents
  • Submission to Ethics Committees and Health Authorities (local & central)
  • Site contracting negotiations
  • Amendment Report and Request
  • Insurance Policy processing