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Your Partner in Scientific and Regulatory Solutions for Nicotine, Tobacco, and Cannabis Products, Focused on Harm Reduction, and Committed to Delivering Clarity, Precision, and Innovation in the Protection of Public Health

A Diversity of Clients. A Wealth of Expertise.

From global, multibillion-dollar corporations to small, privately held companies, Sapphire Sciences partners with a wide range of clients. Our team brings decades of experience in navigating regulatory landscapes and developing scientific strategies tailored to the unique needs of each organization.

Sapphire Sciences boasts a world-class team of senior-level scientists, clinicians, and engineers and a network of over 300 consultants. Our areas of expertise include:

  • Chemistry and Good Manufacturing Practices (GMPs)
  • Consumer research, data science, literature reviews, and statistical modeling
  • Product development and materials characterization
  • Regulatory engagement and postmarket surveillance
  • Toxicology, pharmacology, and epidemiology

With this diverse network, we can assemble custom project teams of any size to meet your needs.

What We Do

We provide comprehensive scientific and regulatory solutions to clients engaging with regulatory authorities, including the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada. Our services are designed to deliver trusted, data-driven insights that support compliance, innovation, and public health, including preparation of PMTAs, SEs, MRTPAs and TPMFs.

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Who We Serve

Our clients develop nicotine, tobacco, and cannabis products that focus on harm reduction, ranging from multinational corporations to small, entrepreneurial ventures. Whether you need strategic support for a complex regulatory submission or targeted scientific expertise, Sapphire Sciences is your trusted partner.

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PMTA Expertise You Can Count On

E-Liquid Products
ENDS Products
Oral Nicotine Products
Grouped PMTAs
MGOs

Our clients rely on us to create comprehensive PMTA roadmaps that guide them through every step of the process:

    • Setting goals and understanding requirements
    • Designing and executing regulatory-facing studies
    • Developing strategies and preparing complete submissions
    • Providing postsubmission support, including deficiency letter responses and postmarket reporting
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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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