The FDA is strongly encouraging Industry to move from paper to electronic submissions in order to increase review efficiency, minimize delays in routing and tracking, and reduce archiving costs. The Common Technical Document (CTD) format is preferred for electronic submissions and is the only format accepted by CDER.

It requires content expertise — professionals who understand process, facility, and assay validation; understand FDA expectations for preclinical and clinical data presentation and discussion; and are familiar with the reviewer expectations in the various FDA review divisions. We have assisted clients with hundreds of INDs and dozens of BLAs, and now prepare almost all FDA submissions in the eCTD format.  Biologics Consulting Group, Inc. (BCG) sends electronic submissions to both the Center for Biologics Evaluation and Research (CBER) and Center for Drugs Evaluation and Research (CDER) including ANDAs.

The advantages of electronic submissions include:

• Increased efficiency of FDA review via:
  • Searchable documents
  • Ability to compare multiple versions of documents (e.g. clinical protocols, product labeling)
  • Cut and paste functionality for formulating review
• Reviewers have instant access to entirety of IND/BLA/NDA submissions throughout their lifecycle whereas internal routing of paper submissions to a reviewer can take several days
  
• Advantages in the above 2 bullets also apply on the industry side, allowing a company to respond faster to questions from the FDA
  
• Can use FDA Gateway to deliver submissions to reviewer in a matter of minutes versus 3-7 days for paper
  
• An electronic IND can be readily leveraged for an eventual a license application
  
• Significantly reduces storage space for archiving submissions
  
• Significantly reduces cost of shipping submissions

BCG's electronic submission services include:

• QC and re-formatting of source documents to meet FDA electronic submissions specifications
• QC of source documents for accuracy of cross-references
• Conversion of source documents to PDF format
• Creation of bookmarks and hyperlinks in PDF documents per FDA specifications
• Publishing of IND, MF, BLA, NDA, ANDA submissions in eCTD and legacy format
• eCTD validation (includes: verification of PDF links, check for PDF optimization, removal of empty leaves, check for missing files, MD5 checksum update/verification, verification of XML backbone, check for compliance with ICH file/folder naming convention)

BCG experience includes:

• Publishing and active maintenance of INDs, MFs, BLAs, NDAs, PMAs
• Submissions to CBER and CDER
• Publishing in legacy, hybrid (eCTD with PDF backbone), and eCTD formats
• Submission via media and the FDA Electronic Submissions Gateway (ESG)
• Detailed knowledge of electronic submissions guidance and FDA preferences
• Electronic Submissions Staff has Regulatory and Publishing Experience and includes former FDA electronic submissions personnel

While FDA currently accepts both paper and electronic submissions, electronic review will eventually become the standard process. Making the transition now will put companies ahead of the game, leaving them well prepared when electronic submissions become mandatory.

Mr. Dan Offringa, ex-CBER Electronic Document Room IT Specialist, heads the BCG electronic submissions group. We welcome client inquiries as to how we can meet your e-publishing needs.

Contact CEO Jim Kenimer, Ph.D. or Mr. Dan Offringa to inquire about BCG's e-submission services.