Clinical regulatory services

 

Convex has extensive experience with the regulatory submission of documents for clinical trial authorization by

the Bulgarian Drug Agency, the Ethics Committee for Multicenter Trials and/or Local Ethics Committees.

Our regulatory services include: 

 

  • Regulatory consulting
  • Creation, compilation, review and adaptation of regulatory documentation
  • Communication with BDA and ECs
  • 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.