The Investigational New Drug (IND) Product Registration solution enables users to complete all required web-form documentation and generate the final PDF bundle of that documentation for submission to relevant health authorities.

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A highly efficient BPM solution for product registration process

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Life Sciences products must be registered with the authorized Life Sciences board before they can be sold, offered for sale, distributed or possessed for sale, distribution or other use.

The IND Product Registration solution addresses the generation of form 1571 for the registration of a new drug application. A new drug application is created which generates form 1571 with additional content that is selected during the application process and bundled together to send over to the FDA as a product for registering the drug under FDA law.

Also, the BPM solution for product registration addresses actions that can be taken on a particular registration that was already submitted to FDA.

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Key Highlights

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