We released a Pharmaceutical Grade version of Debenu PDF Aerialist, with specialist features for Regulatory Electronic Submissions. The idea is to complement and extend the feature set of Adobe Acrobat®, allowing faster approval time for New Drug Applications, while reducing the lead time for novel drugs to get to market.
Debenu COO, Susana De Abrew, headed up the concept for this new version and explains, “Debenu PDF Aerialist Pharma is designed to assist in the legal compliance requirements required to successfully complete Electronic Submissions to Pharmaceutical Regulatory Authorities globally.”
We created this version is because Debenu PDF Aerialist is already popular amongst management, having been on the market for many years. Speaking with existing customers, we learned that it is used in the U.S. for New Drug Applications (NDA) to the Food and Drug Administration (FDA) and in Europe for eSubmissions to the European Medicines Agency (EMA). In some organizations, it is a part of formal policy to use Debenu PDF Aerialist to assist with applications.
In Australia, with the introduction of the Non-eCTD electronic submissions (NeeS) for human medicinal products by the Therapeutic Goods Administration (TGA), Debenu PDF Aerialist has also been adopted by organizations to deal with the new health sector and legislative reform.
We’re a genuine Technology leader, providing PDF solutions worldwide for leading pharmaceutical businesses over the last decade. Among our customer base are Pfizer, Glaxosmithkline, Abbott and the U.S. FDA. Debenu supports the efforts by all organizations to save time and money by building software that supports best practice in the preparation of Regulatory Electronic Submissions. This is done with unique intellectual property, which becomes available to any user in the license agreements attached to each product.
Automation technology is used in Debenu PDF Aerialist Pharma to improve consistency, reduce manual errors and make it easier to adhere to regulatory requirements. Assisting in the process of application approvals is crucial. The research, development, review and approval of an NDA takes up to 10 years. When Market leading drugs can earn up to US$1 million per day, faster approvals can have a substantial impact on the bottom line.
Debenu PDF Aerialist Pharma contains best-in-class specialist features such as Table of Contents generation, Hypertext Links and Bookmarks, and Link Audit Reporting. These features are requirements in The Common Technical Document (eCTD) referred to in Europe, Japan and the United States (the three regions party to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for human Use (ICH).
Specialist Features in Debenu PDF Aerialist Pharma Edition Include:
- Generate bookmarks based on headings and font styles.
- Audit PDF Links and PDF Bookmarks: Check and report on bookmarks and links across pages, between documents and to Web pages.
- Automatic Keyword Linking in PDF Files: Turn every occurrence of a word or phrase in a PDF into an active hyperlink in a single operation.
- Automatic Page Linking in PDF Files: Automatically generate links to any page numbers. Select a section of a page or document – like an index or table of contents – and automatically add links from all numbers to the corresponding page in the document.
- Automatic Table-of-Contents Generation in PDF Files.
- Build hyperlinked tables of contents for individual documents or collections of documents automatically, working from document metadata, heading styles, bookmarks and more.
“Our customers have confidence in our PDF expertise because we have been designing and building PDF solutions since 1997. Coupled with an in-depth understanding of Regulatory Compliance we are passionate about producing quality products that foster compliance with validated standards. This allows our customers to concentrate on what they do best. It’s our technology, for their success,” says Susana De Abrew, who has 15 years Pharmaceutical experience, specializing in Regulatory and IT Compliance.
Susana De Abrew has provided regulatory compliance and technical consulting to the Pharmaceutical industry for 15 years in the US, Europe and Australia. Now as the Chief Operating Officer of Debenu, this expertise has been brought in-house. Under her leadership, the product range is being advanced with innovative new designs, significant development with a strong focus on product quality.
Debenu PDF Aerialist Pharma comes with a variety of licenses and also is available for a free trial. Visit the product page to find out more information.
