Melbourne, Victoria (PRWEB) November 21, 2013
Debenu, released a Pharmaceutical Grade PDF software specializing in Regulatory Electronic Submissions. Debenu PDF Aerialist Pharma complements and extends the feature set Adobe Acrobat® has, creating a much more powerful solution. Allowing faster approval time for New Drug Applications, while reducing the lead time for novel drugs to get to market.
“Debenu PDF Aerialist Pharma, is designed to assist in the legal compliance requirements required to successfully complete Electronic Submissions to Pharmaceutical Regulatory Authorities globally.” States Susana De Abrew, COO of Debenu.
Popular amongst management, Debenu PDF Aerialist has been on the market for many years. 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 procedure policy to use Debenu 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 been adopted by organizations to deal with the new health sector and legislative reform.
Debenu is a genuine Technology leader, providing PDF solutions worldwide for leading Pharmaceutical businesses over the last decade, among its 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 adopting the best practices in 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 compliance. 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 really impact 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:
“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 to 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 at 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 is one of the world’s most innovative PDF and document management software vendors. Producing revolutionary software and custom solutions for Adobe Acrobat, PDF and other file formats since 2007.
Debenu was founded by the people behind ARTS PDF – a significant plug-in developer for Adobe Acrobat, Planet PDF – the world’s #1 news and forum website for PDF, and Nitro PDF.