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Regulatory Affairs

Opera CRO has huge experience in coordination and preparation of complex multi-national submissions with all major regulatory authorities. Members of our team with expertise in regulatory requirements for a country within the region in which you want to start the clinical trial will provide you with the list of documents required, specific country regulations and timelines for submissions and approval. Starting from contract negotiations, translation requirements and compilation of submission files, we will ensure proper submission with complete and quality documentation.
Opera CRO ensures that clinical trials are, and continue to be, fully compliant with the fast-changing world of rules in all of the countries that a clinical trial is being run in.

Opera CRO provides the following services:
  • National submissions in East and West European Countries and Brazil
  • Contacts and negotiations with Ethic Committees and Regulatory Authorities
  • Obtaining approvals from Ethics Committees and Regulatory Authorities
  • Development/review of informed consent forms
  • Clarification of regulatory requirements
  • Communication with Ethic Committees and Regulatory Authorities throughout a trial
  • Negotiation of clinical trial agreements/contracts
  • Preparing / negotiating / signing (whenever applicable) Insurance contract, and obtaining Insurance certificate
  • Procurement and management of import and export license