Streamlined Regulatory Application Processes

EGeen has detailed knowledge of local local respective institutions on behalf of its clients. In the EU countries, regulatory filing is straightforward regulatory processes and practices and has built solid relationship with mission-critical clinical and regulatory bodies in Ukraine and in the EU countries. In the US, regulatory filing is handled through a well-established partnership. EGeen performs all the work needed for the preparation of Regulatory Agency and Ethics Committee applications and for the submission of finalized applications to the and efficient. The complete process from submission to initiation of the trial takes approximately 45 to 60 days. In Ukraine, both Regulatory Agency (State Pharmacological Center - SPC) as well as Central Ethics Committee (CEC) approvals are required. Combined reviewing process takes approximately 60 to 90 days. EGeen will provide a detailed list of required document upon request.

In the EU countries, regulatory filing is straightforward and efficient. The complete process from submission to initiation of the trial takes approximately 45 to 60 days. In Ukraine, both Regulatory Agency (State Pharmacological Center - SPC) as well as Central Ethics Committee (CEC) approvals are required. Combined reviewing process takes approximately 60 to 90 days. EGeen will provide a detailed list of required document upon request. In the US, our highly experienced partner will handle all Institutional Review Board Review process and FDA communications.