Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959

DocTemplate Document Authoring Tool for Regulatory Submissions and Documents

1. Product Description

  1. FrontEnd DocTemplate is a powerful new authoring tool used  to facilitate the preparation of submission ready documents for the life science industry.  
  2. eCTDirect Templates include a wide selection of the most useful CTD submission templates from Modules 1-5. Complete and practical, out-of-the-box solution for creating CTD submission documents.    
  3. eCTDirect Medical Device Templates include a wide selection of the most useful medical device submission templates, plus a complete package of Medical Device templates and a group of SOPs for managing your documents….a complete and practical, out-of-the-box solution for creating medical device product and submission documents. 

Authoring and Templates

Frontend   Doctemplate authoring tool

Submission-ready, agency-compliant documents are the vital end products of the document management process in the life sciences.  

However, achieving those results requires a consistent approach and a solid infrastructure.  

FrontEnd DocTemplate is a new authoring tool that complements eCTDirect Templates and Procedures and facilitates the creation of multipurpose documents for CTD and eCTD submissions.  

When creating documents, you want adaptable and user friendly tools. Tools that help you format with ease and make changes a breeze. With FrontEnd DocTemplate, you simply click your way to well formatted documents….. saving time;  eliminating non-compliant glitches.

eCTDirect Templates and Procedures

Authoring submission-ready documents throughout your organization requires the use of well formatted and easy-to-use templates.  

We provide templates for a wide selection of the most useful CTD submission templates from Modules 1-5, plus a complete package of Medical Device templates and a group of SOPs.  

By providing the blueprint for text, graphics, styles and formatting, these  templates & procedures minimize many  repetitious and time-consuming authoring  functions. Even authors with limited knowledge of MS Word can use them.  

Together with the FrontEnd DocTemplate authoring tool, they are a  practical solution to achieving agency mandated consistency and increasing productivity at the critical front end of the document management process.

Frontend DocTemplate Features

Convenient Toolbars at Hand. A powerful palette of tools and functions with the FrontEnd  DocTemplate toolbar docked to MS Word’s interface. An accessory Symbol toolbar inserts common pharma symbols. A Toggle Bullet Toolbar provides even more authoring functions.

Consistent Styles & Formatting Maintain consistent formatting with FrontEnd DocTemplate. 8 upper-level numbered headings, accompanying text styles, plus many other special styles that help format documents.

High Level Functionality

CTD Prefixes, Endnote References Cross References, Figures and Tables, Table of Contents, Appendices, and more are easy to deal with using FrontEnd DocTemplate. The automated 6-Point  “Technical Checklist” makes sure its right.

Super Adaptability  Switch landscape format to portrait;  Change Letter to A4 size, Set language, Version control….all at the click of a button.

Demos and samples are available on request. Contact or Call 408 733 1199

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our customized product based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 90 % > 90 % > 90 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our product. Company size is based on annual sales as per FDA classification.

3. Price

$ or Call