What We Do

Delivering Scientific Solutions with Clarity, Precision, and Innovation

At Sapphire Sciences we are dedicated to providing trusted, data-driven insights and innovative solutions to address complex scientific and regulatory challenges. Guided by our core principle—Appropriate for the Protection of Public Health (APPH)—we offer an expanded suite of services designed to meet the evolving needs of our clients.

Whether defined for, narrow-scope projects or long-term, strategic support, our multidisciplinary teams collaborate with our clients to provide a custom, right-size approach. We pride ourselves on being a transparent, highly experienced partner, committed to delivering tailored solutions with clarity, precision, and sensitivity to your unique needs.

Regulatory Services:

Our expert regulatory team provides comprehensive support for navigating complex regulatory landscapes, including:

Preparation and submission of
- Premarket Tobacco Application (PMTA)
- Substantial Equivalent (SE)
- Modified Risk Tobacco Product (MRTP)
- Tobacco Product Master File (TPMF) applications
Regulatory strategy development
FDA briefing documents and Advisory Committee Meetings (Ad Coms)
Deficiency letter responses and communications with FDA and global authorities
Risk assessments and APPH determinations
Study design and analysis of harmful and potentially harmful constituents (HPHCs)

Scientific Services:

Our scientific expertise spans a wide range of areas to support product innovation and safety:

Scientific writing
Product evaluation, design and testing
Institutional Review Board (IRB) submissions
Development and review of Quality Management Systems (QMS)
Good Manufacturing Practices (GMPs)
Consumer research and population modeling
Systematic and comprehensive literature reviews
Toxicological analyses
Clinical study design
Chemistry, Manufacturing, Controls (CMC) guidance – review, audit, repair, report
Scientific litigation support
Publishing management, including eTTD (electronic tobacco document) submissions

Enhanced Capabilities for 2025

We are thrilled to introduce additional service areas, reflecting our commitment to innovation and excellence:

- Real-World Data (RWD) & Real-World Evidence (RWE): Experienced epidemiologists and health outcomes experts deliver impactful evidence to inform strategies.
- Data Science & Advanced Analytics: Cutting-edge approaches to uncover actionable insights.
- Expanded Toxicology & Chemistry Services: Expert analysis to ensure product safety and regulatory compliance.
- Product Development: Innovative solutions from concept to market, supported by leading industry experts.

Our Approach to Regulatory Success

Guiding Clients Through the PMTA Process

At Sapphire Sciences, we specialize in guiding clients through the complex and often daunting process of preparing and submitting Premarket Tobacco Product Applications (PMTAs). Many of our clients come to us at the start of their PMTA journey, seeking expertise in designing regulatory-facing studies and crafting comprehensive applications.

Our team develops a tailored PMTA roadmap for each client, offering support at every stage:

Goal Setting & Strategic Planning: We work with you to define clear objectives and establish a path forward.
Study Design & Execution: From conceptualization to data collection, our experts design studies that meet regulatory requirements.
Application Preparation & Submission: We compile all necessary data and documentation into a polished, complete submission package.
Post-Submission Support: Our services extend beyond submission, providing follow-up correspondence, responses to deficiency letters, postmarket surveillance, and annual reporting.

Our mission is to ensure a seamless and successful PMTA process, saving you time and resources while maintaining the highest standards of quality.