Regulatory services

• 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.