During realization of many projects MED-NET had collected rich experience to manage the Regulatory submission and since 2004 the Company is able to manage the whole process:
• EUDRACT database submission;
• collecting all essential documents from investigators and sponsor;
• verification of consistency of essential documents with applicable law regulations;
• preparation application and letters to Regulatory and EC;
• submission of the application and whole documentation package to Regulatory and EC;
• ongoing contacts with Regulatory regarding study related issues.
MED-NET is effective in obtaining Regulatory and EC approval within minimal time defined by Polish law regulations.