The FDA has mandated that all regulatory submissions be in the eCTD format in the near future. For small bio-pharmaceutical companies, the fastest and most efficient way to transition from paper-based submissions to eCTD submissions is outsourcing. In as much time as it takes to select a new vendor and sign the contract, companies can say goodbye to boxing up press-board binders and say hello to eCTD. Although making the decision to switch really is this easy, companies still need to develop a submission and document management strategy that will address both short-term and long-term goals. The business should evaluate options for eCTD outsourcing, implementing eCTD submission capability in-house, and solutions for electronic document management.
Transitioning to eCTD inevitably requires change. To plan the transition, you must determine your short and long-term objectives, how document control will be handled, and what process changes are needed.
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