Our Services

The Pathway To Approval

Businesses that haven’t already initiated key processes are at risk of missing important deadlines for FDA-PMTA compliance. Obtaining and organizing the data needed for your product applications can be difficult and time consuming, and it’s possible to encounter complications along the way. GegaHelix keeps your business a step ahead with our accelerated, three-phase action plan. With this approach, we can eliminate the guesswork and provide a successful, individualized strategy for your brand.

Preliminary Product Risk Assessment and an Introductory Meeting with FDA

  • Assessment of Product’s Composition
  • Preliminary Risk Analysis
  • Comprehensive Toxicological Review of Constituents: Health Summary, Acute exposure, subchronic exposure, carcinogenicity, mutagenicity, reproductive and developmental toxicity, Behavioral and nervous system toxicity, Physiological effects, Bacterial Mutagenicity, Germ Cell Mutagenicity, Mammalian cell mutagenicity, Rodent Cytotoxicity, Addiction Propensity, Ingredient chemical reactivity, and pyrolytic behavior of ingredient, etc.,

All of the above information will be bridged to assess risks associated with your products.
Note: Our scientists will perform these evaluations with substantial evidence and numeric algorithms to analyze your compositions. This is a key justification for FDA to minimize expensive clinical and non-clinical studies requirements.

Analytical Testing, Computational Modeling, Clinical and Nonclinical Studies

  • Computational Modeling to Evaluate Product Risks to Humans and Environment, at both ingredient and whole mixture level (includes various nicotine strengths)
  • Comprehensive Emissions Testing Harmful and Potentially Harmful Constituents Analysis (HPHCs) (includes various nicotine strengths)
  • Toxicity Assessment of Products Based on Emissions and Computational Toxicity Data (includes various nicotine strengths)
  • Product Stability Testing (performed at low, medium and highest strengths)
  • Non-clinical: In vitro Toxicity Testing (performed at low, medium and highest nicotine strengths)
  • Non-clinical: Pharmacokinetic Tests for Systemic Toxicity Assessment in Rodents*
  • Environmental Risk Assessment Studies (includes various nicotine strengths)
  • Clinical: Studies in Humans*

*Our scientists will determine whether your product requires this test. In most cases, our computational modeling substitutes this requirement.

Preparation and submission of PMTA

Summary of risk analysis, computational modeling data, analytical testing, nonclinical, clinical studies, environmental assessment and detailed product description. Prepared in the US FDA eCTD (electronic common technical document) format.