Gegahelix | about us
Your Trusted Partner in FDA Regulatory Compliance
At Gegahelix, we are dedicated to empowering tobacco and nicotine product manufacturers with the expertise, tools, and support needed to navigate the complex landscape of FDA regulations. Our mission is to make PMTA submissions, MoCRA compliance, and regulatory success accessible, efficient, and reliable for businesses of all sizes.
Our Story
Gegahelix was founded by Dr. Rakesh Guduru, Ph.D., with a singular mission: to simplify and streamline the FDA PMTA compliance process. With over a decade of experience as a regulatory consulting expert in the tobacco industry, Dr. Guduru possesses unparalleled insight into the complexities of this evolving landscape.
Recognizing the challenges that e-liquid businesses and tobacco product manufacturers face in navigating the intricate world of FDA regulations, Dr. Guduru established Gegahelix to bridge the gap between regulatory requirements and practical business needs. His vision was to create a company that would not only understand the science behind compliance but also revolutionize how it's delivered.
At Gegahelix, we are committed to driving success through compliance, ensuring that our clients remain at the forefront of industry standards while maintaining their competitive edge in the marketplace.
What Sets Us Apart
Automation & Process Optimization
Our strength at Gegahelix lies in our dedication to automation and process optimization. We excel in expediting PMTA documentation and filings, empowering e-liquid businesses to navigate the regulatory maze efficiently and with confidence. Through innovative technology and streamlined workflows, we've transformed what was once a months-long process into a manageable, predictable timeline.
Decade of Specialized Expertise
Led by Dr. Rakesh Guduru's decade-plus experience in tobacco industry regulatory consulting, our team brings deep, specialized knowledge that goes beyond theoretical understanding. We've lived through the evolution of FDA tobacco regulations and understand the nuances that can make or break a submission.
Proven Track Record
With over 150 successful PMTA submissions and a 100% Acceptance for Review (AFR) rate, our results speak for themselves. Every client we've worked with has achieved the regulatory milestones necessary to continue operating in the U.S. market.
E-Liquid Industry Focus
While we serve various sectors, our core expertise centers on e-liquid businesses and ENDS manufacturers. This focused approach allows us to deliver highly specialized solutions that address the unique challenges and opportunities within this dynamic industry.
Our Expertise
- Premarket Tobacco Product Applications (PMTA)
- MoCRA Compliance for Cosmetic Products
- Toxicological Risk Assessments (TRA)
- Ingredient Safety Evaluations
- Environmental Risk Assessments
- Permissible Daily Exposure (PDE) Analysis
- HPHC Testing and Analysis
- Manufacturing and Quality Compliance
- Labeling and Marketing Review
- Post-Market Surveillance and Reporting
Industries We Serve
- Electronic Nicotine Delivery Systems (ENDS)
- E-liquid and Vape Manufacturers
- Nicotine Pouch Brands
- Oral Nicotine Products (Gums, Lozenges, Sprays)
- Heated Tobacco Products
- Cosmetic and Personal Care Brands
- Contract Manufacturers and OEMs
- Regulatory Consulting Firms
- Investment Groups and Private Equity
- International Brands Entering U.S. Markets
Our Values
Scientific Integrity
Every recommendation we make is grounded in peer-reviewed science and regulatory best practices. We never compromise on the quality or accuracy of our work.
Transparency
We believe in clear communication, realistic timelines, and honest assessments. You'll always know where your project stands and what to expect next.
Innovation
We continuously invest in new technologies, databases, and methodologies to stay ahead of regulatory changes and provide our clients with the most efficient solutions available.
Partnership
We don't just provide services—we become an extension of your team, invested in your long-term success and growth in the regulated marketplace.
Why Choose Gegahelix
- 100% Success Rate in PMTA Acceptance for Review
- Former FDA Reviewers on Staff
- Proprietary Toxicology and PDE Databases
- Rapid Turnaround Times Without Compromising Quality
- Scalable Solutions for Startups to Enterprise
- Comprehensive Post-Submission Support
- Global Regulatory Knowledge and Experience
- Cutting-Edge Technology and Methodologies
- Dedicated Project Management and Communication
- Competitive Pricing with Transparent Fee Structure
Our Commitment to You
At Gegahelix, we understand that regulatory compliance is not just about meeting requirements—it's about enabling innovation, protecting public health, and building sustainable businesses. We are committed to being your trusted partner every step of the way, from initial consultation to market success and beyond.
When you work with Gegahelix, you're not just hiring a consultant—you're gaining a team of experts who are as invested in your success as you are. Together, we'll navigate the regulatory landscape and turn compliance challenges into competitive advantages.
Ready to experience the Gegahelix difference? Contact us today to discuss how we can support your regulatory goals and accelerate your path to market.
Ready to Work with Gegahelix?
Whether you're just starting your regulatory journey or need expert support for complex compliance challenges, our team is here to help. Contact us today to discuss your specific needs and discover how Gegahelix can accelerate your path to market success.
Let's turn regulatory compliance into your competitive advantage.