Quality Management in Claim Substantiation

(201) 331-9300

Published by our sponsorsSee case studies

Mineral sunscreen whitening study, NCT05565625 ↗

Skin hydration and health study ↗

18-week hyperpigmentation study, NCT07136766 ↗

12-week eye cream study, NCT05807620 ↗

Cutometer Dual MPA 580 instrument with its VCS equipment ID label

Quality Management for Consumer Product Testing

With our focus on transparency and ethical practices, we developed a tailored Quality Management System (QMS) specifically for Clinical Testing on Consumer Products.

Because our studies involve human participants, our QMS is based on ICH Good Clinical Practice (GCP) guidelines. We also incorporate applicable FDA regulatory requirements, including 21 CFR Part 11 principles for electronic records and electronic signatures, where applicable.

In addition, our QMS takes input from relevant Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) principles, in areas such as sample handling, documentation and environmental conditions.

Validated Claim Support is ISO 9001:2015 Certified with TÜV Rheinland as of November 2025.

ANAB accredited, certified to ISO 9001:2015 by TÜV Rheinland

VCS Quality Policy

At Validated Claim Support (VCS), our mission is to be the leading provider of clinical testing services in the skincare and cosmetic product efficacy sector. We are committed to delivering the highest quality services that meet and exceed the expectations of our clients, while ensuring compliance with GCP, ISO 9001, and FDA regulations.

Our Commitment to Quality

Personalized Service: We pride ourselves on offering a unique and highly personalized strategy for clinical testing. Our experienced team leverages their extensive knowledge in skincare trials and cosmetic product efficacy to tailor our services to the specific needs of each client.
Efficiency and Accountability: VCS provides efficient and accountable services. We continuously strive to improve our processes to deliver timely and reliable results, ensuring that our clients receive the highest value at an affordable price.
Client Satisfaction: We understand the critical importance of claim support in the skincare and cosmetic industries. Our goal is to foster long-term partnerships with our clients by consistently meeting their requirements and enhancing their satisfaction through personalized service and communication.
Compliance and Integrity: We adhere to the highest standards of quality and regulatory compliance. Our commitment to GCP, ISO 9001, and FDA regulations ensures that all our clinical studies are conducted ethically, accurately, and transparently.
Continuous Improvement: At VCS we are committed to continuous improvement. We regularly review and refine our quality management system to enhance our services, processes, and performance based on internal and external inputs. Feedback from our clients and team members is integral to our improvement efforts.

Our Quality Objectives

Achieve ≥90% client satisfaction score in sponsor solicited surveys.
Deliver ≥90% of study draft reports on or before agreed timelines.
Maintain ≥90% completion of employee training.

These objectives are measured, reviewed, and communicated across the organization to ensure alignment with client expectations and continual improvement of our quality performance.

FDA Registered and Inspected

VCS maintains an FDA drug establishment registration, originally obtained prior to opening our doors in July 2019.

Our current registration is publicly listed in the FDA’s Drug Establishments Current Registration Site (DECRS), under the business operation classification “Analysis.”

We completed our first multi-day site inspection August 24th, 2020 and we’re proud to note that we had no major findings.

We believe in transparency regarding our regulatory status and distinguish FDA establishment registration from FDA approval, or authorization to test commercial drug products.

Our FDA registration can be independently verified through the FDA’s public database: https://www.accessdata.fda.gov/scripts/cder/drls/index.cfm

Vapometer with its VCS equipment ID label during a skin measurement

VCS technician taking a skin measurement on a panelist's forehead

Training in Skincare Clinical Research

Our commitment to continuous improvement relies heavily on employee and management training. Of primary concern are Good Clinical Practices certifications, HIPAA training, and data protection/privacy training for all employees across the organization.

Our training records are available upon request.

Quality Documentation in Claim Support

Because VCS was founded and developed from the ground up, we were able to take a unique approach to our quality system. All of our current documentation is digitally stored in a secure, 2 factor protected cloud-based system controlled through Microsoft’s security suite.

Our Quality Documentation is reviewed in accordance with a defined review schedule or more frequently as needed and is available upon request.

Consumer Product Safety and Privacy Protection

Quality Management goes hand in hand with Data Protection and Privacy, and our training ensures that our panelists’ personal information is private and confidential.

With the help of our Datacapt clinical trial management system and our training processes, you can rest assured that our data and panelists are well guarded, safe, and secure.

How Every Study is Quality Checked

Every VCS study runs in accordance with a protocol that has been approved by our Quality Department and the client. Before a final report is released, our Quality Department has reviewed the study from start to finish: the protocol against the signed quote, every signed consent form, product-use reconciliation, and the raw data exported from Datacapt and our instrument software against the result tables in the report. Protocol amendments, deviations and adverse events are documented, and every finding is documented and resolved before sign-off.

Panelist cleansing her face before measurements under study conditions

Expert Clinical Grading

Trained graders score visible change

Supports claims like “Clinically proven to reduce the appearance of fine lines and wrinkles”

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Biomarkers and Microbiome

Tape strips, swabs and collections

Supports claims like “Microbiome friendly” and “Won’t disrupt the skin’s natural microbiome”

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Biophysical Instrumentation

Hydration, TEWL, elasticity, color

Supports claims like “Hydrates by up to 87% in as little as one use”

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Peer-Reviewed Writing

Clinical and scientific publications

Scientifically validated study summaries for publication in peer-reviewed medical journals

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Before and After Photography

Controlled, reproducible clinical imaging

Supports claims like “Up to a 44% reduction in redness in as little as 2 weeks”

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Consumer Perception

Panelist questionnaires and self-assessment

Supports claims such as “97% of women agreed their skin felt smoother and more supple”

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About Validated Claim Support

Validated Claim Support’s experienced clinical testing team has pooled their vast claim support knowledge in the skincare trials and cosmetic product efficacy space to develop a unique and highly personalized strategy. We provide a distinctive service category that is particularly hard to find: highly personalized efficient service and accountability at an affordable price.

Meet the Clinical ExpertsThe scientists and graders behind every studyLearn more →

Quality Management in Claim SubstantiationHow we keep study data audit-readyYou are here

Data Protection and PrivacyHow we protect sponsor and panelist dataLearn more →Testing Laboratory PartnersPartner labs for tests outside our scopeLearn more →Clinical Testing Laboratory TourInside our Teaneck, NJ facilityLearn more →Sample Handling and Environmental PolicyHow we receive, store and track samplesLearn more →Commitment to Diversity in the WorkplaceHow we build a diverse team and panelLearn more →Ethics & Code of ConductThe standards our team works byLearn more →

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Start a Conversation About Your Product Study

Tell us about your product, your intended claims, and your timeline. Our business development team will review your needs and follow up with a customized proposal, typically within one business day. There is no cost for the initial consultation or study design review.

Get a quote Call (201) 331-9300

FAQ

Quality Management in Claim Substantiation: Frequently Asked Questions

What quality standards does Validated Claim Support follow?

VCS built its own Quality Management System as a hybrid of Good Clinical Practices, Good Manufacturing Practices and Good Laboratory Practices. Studies are conducted in accordance with ICH GCP guidelines, with secondary consideration given to FDA GMP requirements associated with our registration, and applicable GLP principles related to sample handling and environmental control.

Is Validated Claim Support ISO certified?

Yes. VCS is ISO 9001:2015 certified with TÜV Rheinland of North America since November 2025.

When did Validated Claim Support register with the FDA, and has it been inspected?

VCS registered with the FDA as an analytical testing laboratory before opening in July 2019. It completed multi-day FDA site inspections in August 2020 (with no major findings) and again in May 2025. VCS is listed as a current drug establishment registration site on the FDA's database.

Can Validated Claim Support handle drug-related claims?

Yes. VCS conducts clinical studies supporting drug-related claims, and claims for personal care devices, alongside basic skincare, haircare and beauty products/devices.

Can I review Validated Claim Support procedures and training records?

Yes. VCS's quality documentation and employee training records are available upon request. Our Quality Documentation is reviewed in accordance with a defined review schedule or more frequently as needed.

How is quality built into each study?

For every study, our Quality Team reviews the protocol, informed consent, raw data and final report before release. Throughout the study, they also review protocol deviations and adverse events.