A to Z – PMTA Preparation and Submission Service

Service Description:

• A to Z – PMTA Preparation and Submission Service includes: Premarket Tobacco Product Application (Part 1114, Subpart B) preparation, application submission (1114.5), content and format preparation (1114.7), FDA formatting and guidelines for eSubmitter submission, general information requirements, descriptive information, samples of new tobacco products or components or parts document preparation for submission, labeling and marketing plans review for submission, Statement of compliance with part 25 review, summary preparation (1114.7), product formulation review, principles of operation review, product testing and analysis information review, manufacturing record review, health risk investigation compliance.
• PMTA and Recordkeeping Requirements Compliance.
  • Premarket Tobacco Product Applications (Part 1114, Subpart B)
    • Application Submission (subsection 1114.5)
      • Submission of a complete application as part of an initial submission per subsection 1114.27 in section VIII.B, FDA may refuse to accept or file an incomplete application for review.
    • Required Content and Format (Proposed subsection 1114.7)
      • General information (as described in subsection 1114.7(c)).
      • Descriptive application information (as described in subsection 1114.7(d)).
      • Product samples (as described in subsection 1114.7(e)).
      • Labeling (as described in subsection 1114.7(f)).
      • Statement of compliance with part 25 (21 CFR part 25) (as described in subsection 1114.7(g)).
      • Summary (as described in subsection 1114.7(h)).
      • Product formulation (as described in subsection 1114.7(i)).
      • Manufacturing (as described in subsection 1114.7(j)).
      • Health risk investigations (as described in subsection 1114.7(k)); and
      • Certification statement (as described in subsection 1114.7(l)).

Requirements:

• • • Send approved company logo and your facility address to be incorporated on the documents, if applicable, to services@consultareinc.com.

• • • Google Meet – Screen Share for discussion. To be scheduled by our Compliance Team, if applicable.
    • Program(s), Policy (or Policies), Procedure(s), and Form(s) if or when developed will require customization, review, and approval for their intended use.
    • Should you need customization assistance, please schedule a complimentary discussion via gmeet screen share with our Compliance Team by emailing services@consultareinc.com.
    • Recommendation and guidance given or implied are based on best practices and the adherence to a regulatory or certification body requirements and may or may not conform to the requirements or the intended use or application.
    • Consult your inhouse Practitioner, Preventive Control Qualified Individual (PCQI) or Qualified Individuals (QI) prior to the implementation of the Program(s), Policy (or Policies), Procedure(s), and Form(s).
    • Program(s), Policy (or Policies), Procedure(s), and Form(s) created requires review and approval by your company’s authorized personnel and qualified personnel.

Deliverables:

• • Required Content and Format
  • • General information (as described in subsection 1114.7(c));
    • Descriptive application information (as described in subsection 1114.7(d));
    • Product samples (as described in subsection 1114.7(e)); – Documentation Review
    • Labeling (as described in subsection 1114.7(f)); – Additional label charges of $749.00 is applicable.
    • Marketing Plan – Regulatory Review
    • Statement of compliance with part 25 (21 CFR part 25) (as described in subsection 1114.7(g));
    • Summary (as described in subsection 1114.7(h)); – Preparation
    • Product formulation (as described in subsection 1114.7(i));
      • Formulation and Realization Assessment and Review
      • Fraud Vulnerability Assessment Review – Supplier and Material
      • Constituents Review
      • Shelf-Life Stability Study Monitoring Review
      • Storage and Handling Review
      • Testing Lab Qualification Review
      • Container Closure Integrity Assessment
      • Statement Reviews
      • Microbial Assessment Review
    • Manufacturing (as described in subsection 1114.7(j));
      • HACCP – Hazard Analysis Critical Control Point Development
      • HACCP Verification and Validation Review
      • QCP – Quality Control Plan
      • Process Narrative Review
      • Process Controls Review
      • Preventive Controls Review
      • Employee Qualification Review
      • Supplier Approval Program Development
      • Foreign Supplier Approval Program Development
      • Complaint Management Program Development
      • Corrective Action and Preventive Action Program Development
      • Testing Protocols Review
      • RVVMP – Records Verification and Validation Management Program Development
      • Lab Qualification Record Review
      • Product Specification Review
      • Positive Product Release Program Development
    • Health risk investigations requirements preparation and review (as described in subsection 1114.7(k));
    • Certification statement preparation and review (as described in subsection 1114.7(l)).
  • PMTA Completed Application Submission to FDA
  • Estimated Completion of PMTA for submission to FDA 10 months.