Regulatory Affairs

SFS has in-depth knowledge and experience in the management, preparation and elaboration of all documentation relating to a clinical trial, from the adaptation of a patient information sheet to the support in the preparation of a clinical protocol, advising on the sample size, main variables of the study.

Additionally, all communication with the Ethical Committees and Regulatory Agencies, can be managed by SFS at any time and regardless of the status, phase or time of recruitment in which a research project is located.

We do
the communication with regulatory agencies, insurance companies, local authorities and ethics committees

We know
and apply the latest legislation and guidance documents.

We adapt
protocols, informed consent forms, drug labeling and other study documents to local and international legislation

We submit
application dossiers, updated information, expedited and periodic safety reports to regulatory agencies and ethics committees.