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.
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