PMTA Documents! (click for example document list)

You will get 29 pre-written PMTA documents.  All documents are written for Open System E-Liquid.  We do not file these for you via CTP.  You will receive a Questionnaire that you will fill out and email back.  This will allow us to pre-populate most of your information right into the documents.  So, all you are doing is reading each one carefully and improving.  You can also add or remove anything that is not applicable.  If you purchase this, please don't think you can just turn them in.  You still need to verify they are correct and properly represent your business.   You still need to create the SOP's (see the GMP purchase if you need to), the policies (GMP), Quality Management Documents (also see GMP), EA's, Cover Letters, and Description sheets. 

examples:

• Risk Assessment Report
• Risk Management Plan
• Risk Management Summary
• NAS Literature Review Product Comparison
• CASAA and Your Company Survey design and Methodology
• Tobacco Product Vigilance
• Environmental Impact Summary

and Many More....

Documents not Provided with this purchase

• Cover Letters (Can Purchase Cover Letter Assistance Package)
• Market Date Documents (Collection of documents to prove your products are on the market)
• LOA's
• GCC Data
• Product List (made from your infile)
• Company Survey Data (Study Methodology and design template form is included)
• Environmental Assessments (Can Purchase EA Assistance Package)
• Description Sheets (Can Purchase Description Sheet Assistance Package)
• 4057
• 4057B

Not included but can be purchased with the GMP Gold Package

• Policies
• Procedures
• Standard Operating Procedures
• Training Documents
• Quality Management Plan

Disclaimer no one can tell you any documents can get you accepted, filed or through to a market order.    We take no responsibility for any decision made by the FDA on your products.  You should have legal counsel review all PMTA submissions.