Disposables 29 PMTA Documents! (click for example document list)

<p>You will get 29 pre-written PMTA documents.&nbsp; All documents are written for Open System E-Liquid.&nbsp; <strong><span style="text-decoration: underline;">We do not file these for you via CTP</span>.</strong>&nbsp; You will receive a Questionnaire that you will fill out and email back.&nbsp; This will allow us to pre-populate most of your information right into the documents.&nbsp; So, all you are doing is reading each one carefully and improving.&nbsp; You can also add or remove anything that is not applicable.&nbsp; If you purchase this, please don't think you can just turn them in.&nbsp; You still need to verify they are correct and properly represent your business.&nbsp; &nbsp;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.&nbsp;</p>

<p>examples:</p>

<ul>

<li>Risk Assessment Report</li>

<li>Risk Management Plan</li>

<li>Risk Management Summary</li>

<li>NAS Literature Review Product Comparison</li>

<li>CASAA and Your Company Survey design and Methodology</li>

<li>Tobacco Product Vigilance</li>

<li>Environmental Impact Summary</li>

</ul>

<p>and Many More....</p>

<p><span style="color: #ff2a00;"><strong>Documents not Provided with this purchase</strong></span></p>

<ul>

<li>Cover Letters (Can Purchase Cover Letter Assistance Package)</li>

<li>Market Date Documents (Collection of documents to prove your products are on the market)</li>

<li>LOA's</li>

<li>GCC Data</li>

<li>Product List (made from your infile)</li>

<li>Company Survey Data (Study Methodology and design template form is included)</li>

<li>Environmental Assessments (<span data-sanitized-data-mce-fragment="1" data-mce-fragment="1">Can Purchase&nbsp;</span>EA Assistance Package)</li>

<li>Description Sheets (<span data-sanitized-data-mce-fragment="1" data-mce-fragment="1">Can Purchase&nbsp;</span>Description Sheet Assistance Package)</li>

</ul>

<p><span style="color: #00aaff;"><strong>Not included but can be purchased with the GMP Gold Package</strong></span></p>

<ul>

<li>Policies</li>

<li>Procedures</li>

<li>Standard Operating Procedures</li>

<li>Training Documents</li>

<li>Quality Management Plan</li>

</ul>

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