Electronic Regulatory Publishing Services

Pharmakey provides electronic submission publishing services using docuBridge, an internationally recognized and validated publishing system of Lorenz Life Sciences Group. The Pharmakey staff has over 15 years of electronic publishing experience with eCTD applications.

Every company and submission is unique. Pharmakey can provide sponsors with a customized approach to submission development that fits the needs of the company and your submission.

Early identification of all existing source documents, creating new documents from templates and following established standards are all key elements for on time, high quality submissions.

Pharmakey can help your organization lay the foundation for this approach early in the process. Customized training seminars are available to assist sponsors with understanding the eCTD format and objectives. Pharmakey will ask the right questions to ensure that nothing is missed and all key components have been considered and discussed.

Document/Report Level Publishing

The electronic publishing process leading towards a regulatory submission typically involves two sequential activities. The first is the preparation of the submission documents and reports in the appropriate electronic format.

Regulatory Submission Level Publishing

The second phase of the electronic publishing process is the submission assembly. Pharmakey uses only Lorenz trained docuBridge publishers for submission level publishing activities.

Document and Submission Quality Control

All document and reports published by Pharmakey undergo a rigorous quality control process. Quality control includes 100% evaluation of all bookmarks, hyperlinks, and the published submission. Pharmakey uses the Lorenz eValidator electronic validation tool that utilizes the most recent FDA validation criteria. After a complete eCTD has been released by quality control and the sponsor, Pharmakey can transmit the submissions directly to FDA. Pharmakey provides the completed submission to sponsors as an electronic download from our server and/or in disk format.

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