ISI partners with Yamanouchi Co. Ltd. to complete The First eCTD of an NCE

The Company

Established in Japan in 1923, Yamanouchi Pharmaceutical Co., Ltd., (Yamanouchi) is recognized as a leader among the Pharmaceutical Industry and has offices around the world. Yamanouchi Pharmaceutical Co., Ltd. is dedicated to research and development, manufacture and marketing of human pharmaceuticals (prescription medicines and consumer healthcare products) in Asia, Europe, and North America.

The Business Challenge

Yamanouchi approached Image Solutions, Inc. (ISI) with a business challenge: electronic compilation of the first fully valid, Step 4 compliant, eCTD of an New Chemical Entity (NCE) to the European Authorities. Additionally, for the same NCE, to make all source documents, both paper and electronic, suitable for an electronic submission dossier in eNDA format for submission to the Food and Drug Administration (FDA) in the United States, nearly simultaneously!

As this would be the first fully valid, Step 4, eCTD of an NCE submitted to any regulatory agency worldwide, and as Yamanouchi had never compiled an eNDA for the FDA, these submissions held utmost significance and would become a corporate first for Yamanouchi Pharmaceutical Co., Ltd.

Challenges facing Yamanouchi included ensuring version control of source documents provided to ISI during the sixteen (16) month life of the project. Furthermore, ISI was chosen to assist with realization of the submission plans for both Europe and the United States.

Given the magnitude of this dual submission project, Yamanouchi was not looking for a vendor to merely process their electronic submission documents but desired a partner to work hand-in-hand with to ensure timely, successful, submission of these two important applications.

ISI's Solution

Image Solutions, Inc., the leading electronic submissions provider of any services vendor, world-wide, is also known for its success as a pioneer in innovative PDF software applications. ISI's work has been recognized by the Smithsonian Institution in Washington DC, for its pioneering role in the movement toward acceptance and standardization of electronic submissions to the FDA. To date, ISI has assisted some of the world's premier pharmaceutical and biotechnology companies with compilation of over 200 electronic submissions, worldwide.

After several meetings between key team members of Image Solutions, Inc. and of Yamanouchi, ISI was selected as the vendor able to meet the exciting challenge of working with Yamanouchi to complete the first fully valid, Step 4, eCTD of an NCE submitted to any regulatory agency worldwide. A cohesive plan was then formed by Yamanouchi to outsource compilation of the e Submission to ISI. By utilizing ISI's team of eSubmission experts, together with Yamanouchi, the problems and issues were resolved.

ISI then provided detailed expectations management and project plans, as well as a thorough outline of each step that would be taken by ISI during the life of this important project. ISI subsequently assembled a team of expert staff dedicated to work on Yamanouchi's dual eCTD & eNDA projects.

Once data was considered locked, the source documents were then sent to ISI headquarters. Over the sixteen (16) month life of the project, ISI received several types of source documents, consisting of electronic data (Word, PDF, SAS) as well as paper. ISI would then process and maintain the documents in the appropriate submission format.

The Results

Thanks in large part to the strong partnership between ISI and Yamanouchi team members, utilizing ISI's experienced staff of trusted eSubmissions experts and proven ISI software tools, including their new ISIToolBox™ Pharma Edition, Yamanouchi was able to successfully submit the first fully valid, Step 4, eCTD of a New Chemical Entity to any regulatory agency world-wide, on time and on budget. The eCTD consisted of 442 files; 131,756 pages; 57,211 hyperlinks; and 50,882 bookmarks!

Likewise, for the same NCE, Yamanouchi successfully submitted a dossier in eNDA format to the FDA, nearly simultaneously, on time and on budget. Just as impressive as the eCTD, the eNDA consisted of 2,155 files; 157,018 pages; 92,217 hyperlinks; and 117,879 bookmarks!

The two submissions are currently awaiting approval by their respective Regulatory Agencies.

The Future

Due to the success of this initial project, and the strong partnership formed between the two teams, Image Solutions, Inc. has become one of Yamanouchi's preferred outsourcing vendors of choice for electronic submissions processing. Both companies look forward to a successful working relationship for many years to come.