Information

Total PMTA Without GMP/SOP, Policies, Quality Management

29 PMTA Documents

Cover Letter Assistance (We Do Them)

Description Sheet Assistance (We do them)

Ea Application Assistance (If you have an ea app already if you do not you will need the New EA APP)

Infile Assistance (infile checked for errors, flavor amounts moved from flavors to PG or VG.)

Total PMTA with GMP (includes the MyGMP system with 172 documents pre-Populated including Quality Management. (Only need if your process are without things like reprocessing, recall, and SUPAC)

• 29 PMTA Documents
• Gold GMP Package
• Cover Letter Assistance (We Do Them)
• Description Sheet Assistance (We do them)
• Ea Application Assistance (If you have an ea app already if you do not you will need the New EA APP)
• Infile Assistance (infile checked for errors, flavor amounts moved from flavors to PG or VG.)

Explanation of Products

29 PMTA supporting documents and summary forms

• 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)

Not included but can be purchased with the GMP Gold Package

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