Premarket Tobacco Application

The Premarket Tobacco Application (PMTA) is a scientifically rigorous and complex submission process, which is available to manufacturers of new tobacco products, including ENDS and e-liquids. The PMTA is designed to determine the product’s safety and population-based health impact, derived from preclinical and clinical studies conducted under GLP and GCP conditions. The submission requires specialized systems and must be submitted to the US FDA through an e-submitters application. Approximately 18-24 months are required to complete a PMTA submission.

CSSi LifeSciences™ can manage and complete the PMTA on your behalf, including:

  • Preclinical and clinical trials
  • Review of literature and toxicology assessments
  • Scientific review and documentation writing
  • Product characterization, analysis and manufacturing assessment
  • Toxicology, stability and emissions testing
  • Hazards risk analysis
  • Complete CMC and GMP support, including preparation of DMFs
  • Document submission and filing with the FDA
  • US FDA representation
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