Regulatory affairs

KCRI provides complete management of clinical study submissions to Ethic Committees/Institutional Review Boards and Regulatory Authorities in all EU countries:

  • initial submissions
  • amendment submissions
  • appeal processes if needed
  • assuring regulatory compliance on passage between preclinical and clinical phase
  • support of 510(k), IDE and CE approval processes

In addition, KCRI advises on regulatory strategies for emerging devices and technologies depending on specific client needs and in consideration of regional differences between countries.