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.