Navigating the Future of Tobacco Publishing
Navigating the Future of Tobacco Publishing
The Evolving Landscape of Tobacco Regulations
As the market for Electronic Nicotine Delivery Systems (ENDS), such as e-cigarettes, continues to grow, so too does the complexity surrounding their regulation. With long-term effects not fully understood, the FDA and the Center for Tobacco Products (CTP) have established new protocols for Premarket Tobacco Applications (PMTA) through the Electronic Tobacco Technical Document (eTTD). Delphinus Consulting, LLC, a sister company of Aquila Solutions, offers specialized eCTD publishing services to help you navigate these rigorous regulatory standards.
Pioneering eTTD Solutions
We are proud to be one of the first publishing groups to create eTTDs based on federal regulations. Our eTTDs have been accepted in all submissions made by our team at Delphinus and clients utilizing our templates. With a deep understanding of the regulatory landscape outlined in United States Code Title 21, Section 387j, we focus on delivering compliant documentation tailored for your needs.
Comprehensive Consultation and Publishing Services
In addition to offering eTTD templates, we provide extensive consulting services to guide your PMTAs and eTTDs through FDA submission. Our team of experts assist clients with project management, including the design of submission layouts and timelines, and meticulous document reviews for proper editing. Our proven track record boasts a 100% success rate for PMTA submissions to the CTP.
Innovative Templates for Seamless Compliance
Our Consulting has developed a unique collection of 57 Microsoft Word-based templates specifically designed to meet eTTD submission standards. These templates are laden with FDA-acceptable structures, descriptive text, and outlines to facilitate your application process. Utilizing our templates can empower you to submit your PMTAs successfully and maintain your market position.
Commitment to Quality and Compliance
We understand the critical importance of accuracy and compliance in tobacco regulatory submissions. Our dedicated team of consulting experts is committed to ensuring that every eTTD we create adheres strictly to FDA guidelines and industry standards. We take a proactive approach by continuously updating our templates and documentation in response to regulatory changes and feedback from the Center for Tobacco Products. This commitment enhances the quality of your submissions and minimizes the risk of delays or rejections, providing you with confidence as you navigate the evolving landscape of tobacco regulation.
Our team at Delphinus Consulting is dedicated to providing comprehensive and effective solutions for tobacco publishing. With our expertise in eCTD publishing and regulatory consulting, we can help you streamline your submissions and achieve compliance. Reach out to us today for more information on our eTTD templates and services. Let Delphinus Consulting be your trusted partner in navigating the evolving tobacco regulatory landscape.