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Connect with ARAC

Thank you for your interest in partnering with Applied Research and Analysis Company (ARAC). We’re excited to explore how our team can support your goals . To streamline the process and help us get to know your needs, we invite you to take a few simple next steps.

SEE BELOW to guide you to:

  • Submit our quick Inquiry Form

  • Book a meeting with Sam Hampsher-Monk, our VP of Global Regulatory Strategy & Client Operations

  • Review and sign our NDA

  • Browse ARAC Online and learn more about how we help companies like yours

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QUICK LINKS: DIRECTORY | EVENTS | BLOG

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Sincerely,


The Executive Team

EXEC TEAM

CONTRACT TIMELINE

1

Sign ARAC’s Non-Disclosure Agreement (NDA)

2

Consultation + review & sign PROPOSAL

3

Sign ARAC’s Statement of Work (SOW) + PROJECT EXECUTION

4

PRE-SUBMISSION MEETING | Consulting, Legal, & FDA

5

Project Completion

Strongly recommended to conduct a PRE-SUBMISSION MEETING, often in partnership with consulting and legal firms + FDA, to help ensure that your regulatory product application strategy and science are well-aligned with FDA expectations, thus increasing the chances of a

successful submission.

SUCCESS STORIES

PMTA AUTHORIZATION

PMTA SWITCHING STUDY - COMPLETE & SUBMITTED TO FDA: E-Liquid Manufacturer

  • Conducted RCT on flavored vs. tobacco-tasting e-liquids

  • Presented findings to FDLI, demonstrating significant reduction in Cigarettes per Day with flavors compared to tobacco-tasting

PMTA SWITCHING STUDY - IN PROGRESS: Disposable Product

  • Switching Study submitted to FDA and IRB in July 2024

  • Fielding in August 2024

MRTPA AUTHORIZATION

PMTA STUDY - COMPLETED:
Disposable & E-Liquid Manufacturer

  • ITP submitted with leading regulatory consulting firm

  • Worked with multiple government agencies to ensure product entrance and compliance.

  • Results to be presented at FDLI & TSRC

PMTA SWITCHING STUDY - COMPLETED: Oral Nicotine Pouch, Lozenge, & Gum

  • Designed & served as client consultant on 6-month actual use study

  • Uniquely designed product distribution process

  • Presented findings at TSRC 2023, with two publications under review in leading scientific publications

PMTA STUDY - COMPLETE & SUBMITTED TO FDA:

  • AGE-GATED ENDs Human Factors & Label Comprehension Study

  • Conducted US-based, in-person mixed-methods HF and LC Study

  • Focused on consumer perceptions, intentions to use, likelihood of misuse, acceptability, and labeling changes.

  • Tested on age-gated vs. non-age-gated device applications

PMTA SWITCHING STUDY - IN PROGRESS: E-Liquid Manufacturer

  • Four-condition Switching Study to assess impact of flavored e-liquids on cessation

  • Submitted to FDA CTP

  • RCT in-field

PMTA TPPI STUDY - COMPLETED: Oral Nicotine Pouch

  • Assessed intentions and perceptions of U.S. users and nonusers

  • Presented findings to PMI, and to be presented at CORESTA

  • Scientific publication to be submitted to peer-reviewed journal August 2024

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