Who We Serve

Diverse Clients. Tailored Solutions.

Sapphire Sciences partners with organizations across a variety of industries, offering solutions that address unique challenges and drive success. From multinational corporations to entrepreneurial ventures, our clients trust us to provide expert guidance and innovative strategies that meet their needs.

Markets Served

We support organizations developing and distributing products in the following markets:

Reduced-Harm Nicotine Products
Electronic Nicotine Delivery Systems (ENDS) and e-Liquids
Modern Oral Nicotine Products Pouches)
Smokeless Tobacco
Nicotine Replacement Therapy (NRT)
Cannabis/Cannabidiol (CBD)
Nutraceuticals/Dietary Supplements
Regulated and Non-Regulated Consumer Products

Functional Areas Served

Our expertise extends across critical business and operational areas:

Regulatory Affairs
Scientific Affairs
Marketing
Legal
Quality Assurance
Data Analytics
Product Management
Product Development

How We Help

Our clients often approach us to tackle complex scientific and regulatory challenges, such as:

Preparing Premarket Tobacco Product Applications (PMTAs) for new and existing products

Developing new products that comply with U.S. FDA requirements

Conducting product formulation evaluations, including Quantitative Risk Assessments (QRA)

Designing and interpreting results from analytical chemistry and toxicology studies

Developing and completing consumer research studies

Enhancing quality management systems to meet regulatory standards

Conducting systematic literature reviews and targeted research

Performing population-modeling assessments

Analyzing national survey data (e.g., Population Assessment of Tobacco and Health [PATH] or National Youth Tobacco Survey [NYTS])

Providing scientific litigation support in areas like intellectual property, product liability,

and mass tort litigation

PMTA Expertise You Can Rely On

E-Liquid Products

ENDS Products

Oral Nicotine Products

Grouped PMTAs

MGOs

We create tailored PMTA roadmaps, guiding our clients through every step of this complex process:

- Goal Setting & Strategic Planning: Establish clear objectives and pathways
- Study Design & Execution: Create regulatory-facing studies to meet FDA requirements
- Application Preparation: Develop a complete submission package
- Postsubmission Support: Manage correspondence, deficiency letter responses, and post-market reporting

Learn More & Get Our PMTA Roadmap

ABOUT SAPPHIRE SCIENCES

Sapphire Sciences is committed to being the leading provider of scientific and regulatory solutions for organizations that develop nicotine, tobacco, and cannabis products that focus on harm reduction. Our mission is rooted in the principle of being Appropriate for the Protection of Public Health (APPH) while delivering innovative solutions to our clients.

We are proud to serve organizations dedicated to creating products with the potential for harm reduction that improve public health outcomes.

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