Chestnut Solutions Inc Chestnut Solutions Inc
 

Authoring and Templates

FrontEnd™ DocTemplate© is Chestnut Solutions Inc.'s (CSI) powerful new authoring tool used to facilitate the preparation of submission documents for the life science industry.

eCTDirect™ Templates and Procedures include a full set of Module 2 and 3 Templates as well as a useful selection of Module 1, 3 and 5 templates, and SOPs for managing your documents... a practical, out-of-the-box solution for creating CTD submission documents.

eCTDirect™ Medical Device Templates include a complete package of the most useful medical device submission templates.

All can be customized to accommodate in-house styles and content.

e-Consulting

CSI helps companies develop new standards and procedures for implementation of electronic document management and electronic submissions.

CSI can help you assess the current gaps in your organization. An eCTD readiness assessment is a helpful tool for a company transitioning to electronic submissions.

CSI advances the development of new processes that support e-submission ready documents, standards for submission operations (e.g. bookmarks, styles) as well as the development of requirements for technology selection and implementation.

Global Submissions

CSI can support all your global submission requirements. Global deployment of submission strategies is supported by CSI’s worldwide network of regulatory professionals as well as through access to our in-house publishing capabilities.

We can also produce PDF submissions (that can be printed on commercial Docutech printers or your in-house printers) in any format; CTD, veterinary, medical device.