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

Dive into our extensive repository that details the toxicological profiles of countless ingredients. Stay informed and make confident decisions.

Toxicology Summaries

Get concise yet comprehensive overviews of various substances, ensuring that you're always a step ahead in understanding the landscape of e-liquid ingredients.

TRA (Toxicological Risk Assessment)

Our specialized TRA service meticulously evaluates the potential health risks associated with e-liquid ingredients, offering clarity and guidance.

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. Premarket Tobacco Product Application (PMTA) process can be a daunting challenge for manufacturers seeking FDA approval for their products. Our consultancy specializes in streamlining this complex regulatory journey, offering end-to-end support that ensures compliance while minimizing delays. From initial product assessments and comprehensive data collection to scientific analysis, toxicological reviews, and submission preparation, we provide expert guidance tailored to your product's unique needs. With a proven track record and a deep understanding of FDA expectations, we help you achieve approval efficiently, enabling your business to focus on innovation and growth in the competitive tobacco product market.

Expert Regulatory Compliance Solutions for MoCRA Compliance

Complying with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is essential for ensuring your cosmetic products meet FDA standards and stay competitive in the market. Our consultancy specializes in guiding brands through the intricacies of MoCRA compliance, offering expert support in ingredient reviews, safety assessments, Good Manufacturing Practices (GMPs), adverse event reporting, and registration requirements. Whether you're updating your processes or launching new products, we provide tailored solutions to ensure your operations align with the latest regulatory standards. With our expertise, you can confidently navigate MoCRA's requirements while focusing on creating exceptional products for your customers.

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