Delphinus Consulting, LLC
Delphinus Consulting, LLC: Your Solution to the Changing Tides of Tobacco Regulatory Publishing
In an era of evolving tobacco regulations, businesses must adapt quickly to ensure compliance while optimizing their operations. Delphinus Consulting, LLC, a sister company to Aquila Solutions, specializes in regulatory consulting, particularly in tobacco regulatory publishing through eTTD submissions. With a reputable track record in guiding companies through the complexities of the regulatory landscape, we are equipped to help your organization adapt and thrive.
About Delphinus: A Pioneer in Tobacco Regulatory Publishing
Delphinus Consulting was established as one of the first companies dedicated to assisting organizations with eTTD Regulatory Publishing. Our team has submitted dozens of Premarket Tobacco Applications (PMTAs) and Tobacco Product Manufacturing Files (TPMFs) to the Center for Tobacco Control. We collaborate closely with the FDA, ensuring that our clients remain informed and prepared for the next steps in compliance.
Our Top Accomplishments with Delphinus Consulting LLC:
10%
Approximate Total SKUS Submitted to CTP by deadline were Delphinus submissions
7500
Approximate products submitted
30+
Applications submitted
2500+
Products under active management
6 Weeks
Average Turn-Around for Full PMTA
Comprehensive Services Tailored for Your Needs
At Delphinus Consulting, we offer a versatile suite of services designed to meet the specific requirements of tobacco regulatory publishing. Our expertise spans all aspects of Electronic Tobacco Technical Document (eTTD) regulatory publishing, ensuring that your submissions comply with the ever-evolving regulatory landscape.
Regulatory Consulting and Strategy
In addition to our publishing services, we provide in-depth regulatory consulting and strategic guidance. Our experienced consultants work closely with you to develop tailored strategies that align with your business objectives and regulatory obligations. We understand the complexities of the regulatory environment, helping you navigate potential challenges with confidence.
Efficient Project Management
Delphinus Consulting prioritizes efficiency and expediency in project management. We recognize the time-sensitive nature of regulatory submissions and are committed to processing your documents promptly without sacrificing quality or compliance. Our streamlined workflows and dedicated team ensure that your regulatory needs are met swiftly and effectively, allowing you to focus on your core business priorities.
PMTA Leaders: Setting Standards in Compliance
Delphinus Consulting was the first to develop PMTA templates for Electronic Tobacco Technical Documents that align with the rigorous regulations outlined in Section 910(b) of the Federal Food, Drug, and Cosmetic Act. These templates are invaluable resources for companies aiming to streamline their submission processes. We continuously update them based on feedback and guidance from the FDA and the Center for Tobacco Products (CTP), ensuring our clients have access to the most current standards in compliance.
Expertise That Makes a Difference
Experienced Team
Our team consists of seasoned pharmaceutical consultants and regulatory experts with extensive backgrounds in tobacco regulations.
In-Depth Knowledge
We possess a comprehensive understanding of the intricacies of tobacco regulatory frameworks and compliance requirements.
Industry Best Practices
By leveraging industry best practices, we effectively navigate the complexities of regulatory submissions and publishing.
Tailored Submissions
Each submission is meticulously crafted to align with regulatory standards, minimizing the risk of delays or rejections.
Accelerated Time to Market
Our expertise instills confidence, enabling you to expedite your product's journey to the market while ensuring compliance.
Fostering Long-Term Partnerships for Sustainable Growth
Our team believes in building long-lasting relationships with our clients, ensuring that we remain a dedicated partner throughout their regulatory journey. By understanding your unique challenges and goals, we foster a collaborative environment that addresses immediate compliance needs and prepares your organization for future regulatory developments. Our ongoing support and strategic insights empower you to stay ahead of the curve, allowing for sustainable growth and success in the ever-evolving tobacco market.
Your Trusted Partner in Regulatory Success
Delphinus Consulting, LLC is here to support you through the changing tides of tobacco regulatory publishing. Our commitment to accuracy, flexibility, and expedience sets us apart in the industry. Contact us today to learn how our regulatory consulting and publishing services can help you achieve compliance and simplify the complexities of tobacco product submissions. With our team at Delphinus Consulting and Aquila Solutions, you can navigate the regulatory landscape with confidence and ease.