Where Human

Insights Drive

Product Success.

Where Human

Insights Drive

Product Success.

Built on a proven track record of supporting successful FDA PMTA authorizations, ARAC provides the scientific and consumer insights needed to guide products from development through commercialization.

10,000+

CONSUMERS' OPINIONS

OBTAINED

4

MARKETING GRANTED

ORDERS SUPPORTED

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PHASE 01

01

Innovation & Product Development

Every successful company starts with early-stage product development based on short-term and long-term consumer insights. ARAC helps manufacturers evaluate concepts, prototypes, and make informed product development decisions.

6 study methods

PHASE 02

02

Regulatory Planning & Pre-Submission

With a product in hand, ARAC helps organizations identify the clinical and behavioral evidence needed to satisfy scientific evidentiary standards of regulatory authorities worldwide.

2 services

1 study method

PHASE 03

03

Human Subjects Studies

Every MGO includes some form of human subjects behavioral data. ARAC designs and executes the Module 5 and Module 6 studies that form the core of every submission.

10 study methods

PHASE 04

04

Post-Authorization & Market Maintenance

ARAC generates and maintains the evidence needed to support claims, meet post-market requirements, and sustain market access.

4 services

3 study methods

PHASE 01

01

Innovation & Product Development

Every successful company starts with early-stage product development based on short-term and long-term consumer insights. ARAC helps manufacturers evaluate concepts, prototypes, and make informed product development decisions.

6 study methods

PHASE 02

02

Regulatory Planning & Pre-Submission

With a product in hand, ARAC helps organizations identify the clinical and behavioral evidence needed to satisfy scientific evidentiary standards of regulatory authorities worldwide.

2 services

1 study method

PHASE 03

03

Human Subjects Studies

Every MGO includes some form of human subjects behavioral data. ARAC designs and executes the Module 5 and Module 6 studies that form the core of every submission.

10 study methods

PHASE 04

04

Post-Authorization & Market Maintenance

ARAC generates and maintains the evidence needed to support claims, meet post-market requirements, and sustain market access.

4 services

3 study methods

Feasibility Study
Concept Testing
Sensory Product Research
Sensory Panel Testing
Label Comprehension Study
Pilot Testing
U.S. Focused: PMTA Pre-Submission Meeting Support
Global Regulatory Scans & International Pathway Support
Regulatory Gap Analysis
Module 5
Pharmacokinetic (PK) Study
Module 5
Abuse Liability Assessment
Module 5
Subjective Effects Study
Module 6
Human Factors Study/Usability Testing
Module 6
Tobacco Product Perception and Intention (TPPI)
Module 6
Randomized Controlled Trial (RCT) / Actual Use Study
Module 6
Longitudinal Cohort Study (LCS)
Module 6
Public Attitude Survey
Module 6
MRTPA Claims Research
Module 5
Product Use/Topography Study
Post-Market Surveillance Plan (PMSS)
Claims Substantiation
Consumer Insights & Competitive Analysis
Reformulation Support
Adverse / Serious Adverse Event Monitoring
Population Modeling
Summary Writing

PHASE 01

01

Innovation & Product Development

Every successful company starts with early-stage product development based on short-term and long-term consumer insights. ARAC helps manufacturers evaluate concepts, prototypes, and make informed product development decisions.

6 study methods

PHASE 02

02

Regulatory Planning & Pre-Submission

With a product in hand, ARAC helps organizations identify the clinical and behavioral evidence needed to satisfy scientific evidentiary standards of regulatory authorities worldwide.

2 services

1 study method

PHASE 03

03

Human Subjects Studies

Every MGO includes some form of human subjects behavioral data. ARAC designs and executes the Module 5 and Module 6 studies that form the core of every submission.

10 study methods

PHASE 04

04

Post-Authorization & Market Maintenance

ARAC generates and maintains the evidence needed to support claims, meet post-market requirements, and sustain market access.

4 services

3 study methods

Feasibility Study
Concept Testing
Sensory Product Research
Sensory Panel Testing
Label Comprehension Study
Pilot Testing
U.S. Focused: PMTA Pre-Submission Meeting Support
Global Regulatory Scans & International Pathway Support
Regulatory Gap Analysis
Module 5
Pharmacokinetic (PK) Study
Module 5
Abuse Liability Assessment
Module 5
Subjective Effects Study
Module 6
Human Factors Study/Usability Testing
Module 6
Tobacco Product Perception and Intention (TPPI)
Module 6
Randomized Controlled Trial (RCT) / Actual Use Study
Module 6
Longitudinal Cohort Study (LCS)
Module 6
Public Attitude Survey
Module 6
MRTPA Claims Research
Module 5
Product Use/Topography Study
Post-Market Surveillance Plan (PMSS)
Claims Substantiation
Consumer Insights & Competitive Analysis
Reformulation Support
Adverse / Serious Adverse Event Monitoring
Population Modeling
Summary Writing
Feasibility Study
Concept Testing
Sensory Product Research
Sensory Panel Testing
Pilot Testing
U.S. Focused: PMTA Pre-Submission Meeting Support
Global Regulatory Scans & International Pathway Support
Regulatory Gap Analysis
Module 5
Pharmacokinetic (PK) Study
Module 5
Abuse Liability Assessment
Module 5
Subjective Effects Study
Module 6
Label Comprehension Study
Module 6
Human Factors Study/Usability Testing
Module 6
Tobacco Product Perceptions. Intentions, & Comprehens. (TPPIC)
Module 6
Randomized Controlled Trial (RCT) / Actual Use Study
Module 6
Longitudinal Cohort Study (LCS)
Module 6
Public Attitude Survey
Module 6
MRTPA Claims Research
Module 5
Product Use/Topography Study
Post-Market Surveillance Plan (PMSS)
Claims Substantiation
Consumer Insights & Competitive Analysis
Reformulation Support
Adverse / Serious Adverse Event Monitoring
Population Modeling