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

Regulatory Electronic Submission Templates

1. Product Description

We have regulatory electronic submission templates for both drugs (eCTD) and medical device (STED) with real examples. The templates will allow you to focus on your company’s core business activities and will benefit you in following ways:

  1. Standardized organization of the marketing application folders

  2. Expedited review process because of easy access to documents and data, ability to copy and paste, and faster navigation

  3. Improved and more efficient communication and correspondence between the agency and the sponsor, especially in case of questions and inquiries

  4. Elimination of the need for compiling, publishing, and shipping of large volumes of paper documents.

  5. Elimination of the need for storage and archiving of huge volumes of paper associated with submission.

  6. The submissions will accommodate full regulatory dossiers, supplements, amendments, and variations.

  7. The submissions will be able to accommodate regional requirements that are represented in regional guidance documents, regulations, and statutes.

  8. The technology will be extensible so that as technology changes, the new electronic solutions can be accommodated.

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 > 40 % > 60 % > 80 %
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