GlobalSubmit Description
No matter how experienced or novice you are with the regulatory submission process, you should not take the risk of your electronic common technical documents (eCTDs) being rejected lightly. This is especially true given the evolving regulatory environment. There are also differences in eCTD submission requirements by region. This makes it difficult to manage the entire document lifecycle and meet your organization's goals for accelerating your release to market. Certara's GlobalSubmit™, eCTD submissions management program, will give your regulatory team the tools to publish, validate, review, and approve your eCTD submitted documents. You can reduce risk and avoid unnecessary steps by using a simplified eCTD submissions process that supports your regulatory department as they race to meet deadlines to deliver treatment to patients. It is crucial that your eCTD submissions are filed as your regulatory department races for treatment delivery and deadlines.