Press Release – May 16th, 2013
May 16th, 2013 Atlanta, GA — The Online eCTD Timeline Calculator — Today in Atlanta, GA, Aquila Solutions, LLC announced the immediate availability of The Online eCTD Timeline Calculator, enabling customers and prospects the opportunity to have free access to high level eCTD project planning expertise online, a first in the electronic publishing arena.
Joshua Boutwell, President and CEO of Aquila Solutions said, ” We are pleased that our expertise in eCTD project planning and publishing is now available to everyone. We hope this timeline calculator will help sponsors plan their projects and save them time and resources. ”
Positive Customer Impact
Customers and prospects have already benefited from utilizing The Online eCTD Timeline Calculator in their current projects. The Online eCTD Timeline Calculator asks a series basic and non-sensitive questions to approximate the size and structure of the final eCTD sequence. It then calculates the number of man-hours necessary to process the gigabytes of data and create a valid eCTD. With Aquila Solutions online calculator, regulatory managers across the globe are no longer in the dark as to the resources they will need for publishing their eCTD submissions. In January of 2013, the FDA released a draft guidance stating the eCTD will be mandatory for all approved applications in 2015 and all development applications in 2016. At that time paper will no longer be accepted and eCTD will be the only approved standard.
Founded in 2011, Aquila Solutions, LLC is a worldwide leader in eCTD Electronic Regulatory Publishing Services. The company offers a wide range of products and services provides finalized documents to deliver a submission ready eCTD. For small sequences, under 1,000 pages and 20 documents, Aquila will provide deliverables according to a standard timeline. For larger sequences Aquila assists as needed with the development of a submission plan and project milestones to speed the publishing process. This includes submission through Aquila’s FDA ESG account if requested.