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.