Drug development and approval process today is a complex and time sensitive undertaking consisting of the following stages:

• Pre-clinical testing
• Investigational new drug application (IND)
• Clinical Trials (Phase 1, 2, and 3 studies)
• New Drug Application (NDA)
• NDA review/approval

NDA filing is a major endeavor where NDA’s typically run 100,000 pages or more. Such filings can be streamlined by providing organized and well-managed data that can be searched and accessed easily to facilitate the review process.

FDA is one of the progressive government agencies that facilitates NDA filing by accepting applications electronically. In fact, in its Electronic Submission Guidelines, FDA has mentioned that the various PDF documents submitted along with a drug approval application should contain a Table of Contents (TOC) as well as bookmarks for TOC entries.

NDA filing should include bookmarks for investigational formulations, validations, batch records, clinical statistics and patient profiles. For instance, bookmarking is a key requirement for Case Report Tabulations (CRTs) and Case Report Forms (CRFs).

FDA requires the pharmaceutical companies to have bookmarks to help the reviewer navigate the PDF patient profiles. For larger patient profiles, a bookmark should be provided to each CRF domain. If all patient profiles for a study are included in one file, the bookmark hierarchy should include each patient by study site.

Each CRF must have PDF bookmarks as part of the comprehensive table of contents required under 314.50(b). FDA recommends bookmarks for each CRF domain and study visit to help the reviewer navigate the CRFs.

Using the convert, merge, and split functions of AMS Auto binder, one can quickly assemble the relevant CRF documents.

Through its Auto and Interactive Bookmarking functions, BMK Application Suite can easily add bookmarks against incoming PDF files. Using its Bookmark import functions, BMK can also bookmark scanned patient data files for a particular study or a particular protocol. Using BMK Audit functions, one can also validate, print, and export bookmarks for one or more PDF files.

Finally, using the Bind function of AMS, one can quickly build Table of Contents for the CRFs and logically bind them together using hyperlinks.

Use of AMS, BMK, and ALR in drug application submission process saves laborious work hours in searching for the required information across documents. Properly organized, bookmarked, and hyperlinked submissions can expedite the drug review/approval process.