Clinical Trials

Regulatory services

Convex CRO has extensive experience with regulatory submission of documents for clinical trials authorization by the Bulgarian Drug Agency (BDA), Ethics Committee for Multicenter Trials (CEC) and/or Local Ethics Committees (LECs). Our regulatory services include:

  • Regulatory consulting
  • Creation, compilation, review and adaptation of regulatory documentation
  • Communication with RA and EC
  • Submission of regulatory files
  • Maintenance of regulatory files post-approval

Whether we are providing expert advice, planning meetings or facilitating communication between the sponsor and the BDA/CEC/LEC, we guide our clients through each step of the approval process by providing unsurpassed regulatory services. All this leads to smooth and faster startup of any trial.