The Electronic Document Management (EDM) Reference Model is intended for biopharmaceutical companies implementing an EDM system or a simple file share to store and prepare documents for regulatory submissions of drugs and biologic products intended for human use. While the model provides the content, a Regulatory Publishing system is still required to assemble and publish a true regulatory submission. The Reference Model is also useful for biopharmaceutical companies needing to organize and transfer documentation assets of a product to another company’s repository under an acquisition or partnership scenario. In this case, the Reference Model provides the common document definition and structure that both companies can share.
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