Streamlining Regulatory Publishing With Submission-Ready PDFs

By Scott Mackey, Director of Product Management, Adlib Software

In order to streamline the submission process, the FDA has introduced eCTDs. The eCTD standard - which will soon evolve to RPS (Regulated Product Submission) - is an interface between industry and the agency for transferring regulatory information while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission.

The highly collaborative and fractured nature of the research and development process means that many of the original source documents that make up eCTD submissions need to be manually reworked. The rework stems from deficiencies inherent in Microsoft Word or the rendering process itself, particularly the inability to retain key navigation information during conversion to PDF. This kind of manual rework is time consuming, prone to error and, not surprisingly, very expensive.

In addition, the documents for an Investigational New Drug Application (IND) or New Drug Application (NDA) submission are always "in play" – constantly under review, endlessly annotated and eternally being "improved." However, these improvements must not corrupt the perfection of the submission. Too often, post-production re-rendering is where critical errors are made or repeated.

The end goal in preparing an NDA submission is the generation of high-quality, submission-compliant PDF documents that accurately and precisely represent the source data. Achieving this goal can be a time consuming and highly iterative process, especially without the right technology in place.