Need help navigating the complex PMTA (Premarket Tobacco Application) process for your new products in the USA market? We provide a complete solution to ensure efficient and effective compliance with FDA regulations, whether you’re launching e-liquids, nicotine pouches, disposable devices, or other NGP products.
Description
In collaboration with our partner, Spark-Lab, we provide a comprehensive solution for navigating the complex PMTA (Premarket Tobacco Application) process required for introducing your NGP products to the USA market. Whether you’re launching e-liquids, nicotine pouches, or other NGPs, our services ensure efficient and effective compliance with FDA regulations.
Why choose our PMTA services?
- Save Time: Streamline the preparation of documentation and studies with expert support.
- Reduce Costs: Minimize expenses on studies and laboratory analyses with optimized processes.
- Simplify Compliance: Easily navigate and understand FDA guidelines with clear guidance.
What we offer:
We provide a comprehensive PMTA submission service – everything you need to get your products FDA-compliant. From start to finish, we provide seamless support to simplify the process and ensure success.
- Documentation preparation: We assist in creating thorough, FDA-compliant PMTA submissions, including required scientific and administrative sections.
- Laboratory testing: Chemical, stability, toxicological, and emissions studies conducted by accredited labs to meet FDA guidelines.
- Strategic planning: Guidance on reducing costs and optimizing timelines through techniques like bracketing, matrixing, and risk assessment.
- Post-submission support: Continued compliance management, including postmarket reporting as required by FDA.
Make your product compliant with regulations – benefits of PMTA approval:
- Legality: The product can be marketed in the USA.
- Consumer trust: The product meets safety standards.
- Competitive advantage: Access to a larger market.
Trust the experience:
? Successful PMTA processes for numerous clients: Each PMTA submission is designed to reflect your product’s unique strengths and requirements.
? Skilled team of experts: Backed by our partner Spark-Lab, we ensure all testing and submissions meet the highest standards of accuracy and ethics.
? Teams of regulatory specialists, toxicologists, microbiologists, pharmacists, chemists.
? Comprehensive support on every step of the process: From documentation preparation to laboratory studies, we streamline every step of the process to save you time and resources.
Partner with us to grow your business
With Chemnovatic and Spark-Lab, navigating the PMTA process is no longer a challenge. We handle everything from preparing documents to providing support after submission, making sure your products meet FDA standards efficiently and effectively.
Whether you’re adding new products or expanding your portfolio in the USA market, we make the PMTA process simple and stress-free.
If you operate in the USA market, you might also be interested in partnering with Chemnovatic – the best nicotine manufacturer – as your nicotine supplier. Purchase our nicotine solutions, crafted with the highest European standards of purity and consistency, and deliver top-quality products to your customers.
At Chemnovatic, we’re here to help you succeed. Let us guide you through the PMTA process and provide you with the best nicotine solutions for your business.
Contact us at sales@chemnovatic.com to get started.
