Testing, Validation and Risk Analysis

Manufacturers of vapor products are required by the US FDA and the European Commission to document the potential risks their products may pose to consumers and require testing and analysis to demonstrate safety, prior to marketing. We can assist in developing a Hazards Risk Analysis and assessment for submission to the US FDA on a Pre-Market Tobacco Application to the FDA and other Competent Authorities.

CSSi LifeSciences™ can provide a wide range of scalable services to support PMTA and EU TPD2 regulatory submissions. Our services include management of:

  • Non clinical and animal studies
  • Toxicology testing
  • Clinical studies and site selection
  • Product testing and analysis
  • GMP characterization
  • Development of Specifications of e-liquids
  • Storage and Stability testing
  • Packaging testing
  • Human Factors testing
  • Components testing
  • Software control and validation
  • Environmental Assessment
Lab clinician with clipboard checking production