What We Do

We are a highly focused regulatory consulting group dedicated to the tobacco space and bring a world class team of tobacco-specific toxicologists, chemists, clinical trial experts in addition to project managers and other various subject matter experts to assist companies with their FDA and other regulatory needs.

We offer complete or partial assistance with PMTA submissions, EU TPD fillings, PACT act compliance, SDS sheet creations, regulatory consulting advice and more.

Founded in 2015, by experts in Tobacco, Pharma and U.S. FDA Compliance, our core team combines 50+ years of expertise in tobacco, medical, pharma, food, and cosmetics and has a successful track history with the FDA.

Although focused on North America, we have established a global footprint including Europe and Asia enabling us to support at all levels including ingredients, design, software, manufacturing, and distribution.

Please contact us to find out what ways we might be able to assist you today!

Our Process

We believe to maximize resource utilization there must be transparency in process, cost, and time.

1. Objective

2. Analyze

3. Strategize

4. Implement

5. Monitor

We believe to maximize resource utilization there must be transparency in process, cost, and time.

Need a PMTA?

We understand the complexities of moving from an unregulated business environment to a regulated one. The PMTA is more than just filling out some forms and making some lab tests and a few clinical trials.

With our team’s vast knowledge of scientific, quality/manufacturing, and regulatory affairs, we are able to offer a solution that eases the burden for our clients in properly submitting the right information into a PMTA and along with navigating the move to a regulated environment.

You deserve a partner that not only has the proven experience with the FDA but also understands the tobacco industry, including ENDS. We recognize what a large commitment in both time and capital you and your shareholders are making and would be honored to be your regulatory partner.

Learn More

Our Services

Regulatory Services

  • FDA PMTA
  • FDA MRTP
  • EU TPD PRODUCT NOTIFICATIONS
  • FDA TOBACCO SE

Non-Clinical (testing Services)

  • CHEMISTRY
  • TOXICOLOGY
  • STABILITY
  • MICROBIOLOGY
  • INGREDIENT/MATERIAL REVIEW

Additional Services

  • SUBMISSION & AMENDMENT PUBLISHING
  • AUDIT SERVICES
  • POSTMARKET SURVEILLANCE
  • PMTA DEFICIENCY PLANNING
  • PACT ACT & EXCISE COMPLIANCE SERVICES
  • QUALITY MANAGEMENT SYSTEMS & GMP COMPLIANCE
  • PRODUCT DEVELOPMENT SUPPORT
  • ENVIRONMENTAL ASSESSMENTS
  • COMPLIANCE TO REGIONAL STANDARDS (FDA CFR’S, AEMSA, PAS, EU, TPD, UL)

Clinical (Individual & Population)

  • ABUSE LIABILITY
  • PERCEPTION STUDIES
  • USE STUDIES
  • HUMAN FACTORS
  • POPULATION MODELING

Risk Assessment

  • PRODUCT RISK ASSESSMENTS
    & RISK PROFILES
  • SE APPLICATIONS
  • TPD NOTIFICATIONS

LEARN HOW TO COMPLY WITH THE PACT ACT FOR ENDS

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Contact Us

Phone
+ 1 (916) 402-5800
Address
103 W Main Street,
Hudson MI 49247

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