WE STRIVE TO BE AN UNPARALLELED PILLAR OF SUPPORT FOR FDA PMTA CONSULTANTS AND E-LIQUID BRANDS. TO THIS END, WE'VE CULTIVATED A RICH ARSENAL OF RESOURCES AND SERVICES:
Our Services
Ingredient Toxicology Databases
A comprehensive toxicology resource by Gegahelix, designed to support FDA PMTA compliance for ENDS, e-liquids, nicotine pouches, and related products through data-driven ingredient safety assessments.
Toxicology Summaries
We offer industry-leading toxicology support for companies preparing PMTAs. Whether you're developing vapor devices, nicotine pouches, gums, lozenges, or other non-combustible nicotine delivery systems.
TRA (Toxicological Risk Assessment)
PMTA-ready toxicological risk assessments (TRA) for ENDS, pouches, gums & lozenges. FDA-compliant exposure modeling and health risk evaluation.
PDE (Permissible Daily Exposures) Database
Navigate our PDE database to gain insights into allowable exposure levels, ensuring safety and compliance.
Environmental Risk Assessment
Assess the potential impact of e-liquids on the environment. Be proactive in ensuring sustainability and ecological responsibility.
Documentation & Submission Assistance
From compiling essential documents to submitting them for regulatory approval, we streamline the process, ensuring a hassle-free experience.
U.S. Premarket Tobacco Product Applications (PMTA)
Navigating the U.S. PMTA process with end-to-end support that ensures compliance while minimizing delays and achieving FDA approval efficiently.
Expert Regulatory Compliance Solutions for MoCRA
Guiding brands through MoCRA compliance with expert support in ingredient reviews, safety assessments, and registration requirements.