5 STAR RATED SERVICES

OTC And Drug Product Clinical Support

Dandruff, SPF, Redness Reduction, Acne Products, Psoriasis, Melasma Studies, and Custom Anti Aging Support

Over The Counter Topical Claims

As an FDA Registered and Inspected Lab facility, VCS can help you maximize your OTC level claims and conduct pilot research or proof of concept studies on new, novel ingredients.

We have extensive experience working with standard “drug level” skincare claims, and we can help ensure that you are not overstating your goals or product performance and are staying in line with local and international regulatory requirements.

To Be or Not to Be (a Drug Product), That is the Question. . .

OTC level claims generally have posted regulatory guidelines as well as best industry practices for safety and efficacy, so it is particularly important to bring in a claims consultant for relevant international markets of interest.

Whether you decide to market your product as a drug or a skincare/cosmetic product, VCS has your back.

Main Areas of Focus for OTC and Topical Research

We have extensive experience working with the following OTC product categories:

OTC Claims

Anti-Inflammatories
SPF and Sun Protection Products
Dandruff Control Products
Eczema, Psoriasis Treatments
Acne Products
Scar care and Wound Healing
Anti-Pruritic and Anti-Itch Products
Hyperpigmentation and Age Spot Reduction
Chronic Dermatitis
Hair Regrowth/Hair Growth
Eyelash Growth
Anti Aging and Wrinkle Reduction
Collagen and Skin Firmness
Cellular Regeneration

When conducting drug level claims validation, it is particularly important to ensure you are using an FDA registered and inspected testing facility for compliance.

In addition to these OTC categories, VCS also has extensive secondary experience designing novel outside the box pilot and full-blown clinical studies, and we would be quite happy to discuss your next clinical study directly with your team.

Give Your Customers A Reason To Believe In Your Brand

Validated Claim Support is comprised of a team that has pooled their vast experiences in the industry together, working on many different facets of clinical studies.

FDA Registered & Inspected Lab
Independent & Privately Held Company
Onsite Product Testers
Ethical & Accurate
Fast Turnaround Time
Over 115 Years Of Combined Experience

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Without a Drug Active, Drug Claims are Strongly Not Recommended

While there are many new natural and homeopathic remedies which can improve the underlying conditions associated with OTC level conditions (lesion counts, oil/sebum reduction, reduction in redness etc) it is imperative that you do not overstep your claims unless you have followed all the respective monograph rules.

Simply stating a word like “Acne,” “Dandruff,” or “Scars” can have drastic implications for a brand. Validated always advises speaking to a claims and label attorney before making any “Drug” oriented claims. When in doubt, we always recommend caution and sticking to softer marketing language.

An “Active” Active Ingredient is a Must

Anytime you use a word like “growth” it references a physiological change in the body, and you can make the fair assumption that the consumer will think “drug product”. This risks triggering regulatory oversight.

VCS can run your hair care study in our full-service hair salon, bridging the gap between take home and professional use products.

We can also bring in our consulting Dermatology group for more detailed grading and assessment criteria.

For non-drug claims, VCS can also look at hair volume and density improvement and hair thickening as functional cosmetic claims without going for the full drug claims.

For more information, please reach out to our team directly.

Skin Tone & Complexion

Haircare Product Efficacy

Visual Skin Changes

Fine Lines Wrinkles

Acne & Pore Reduction

Undereye Products

Anti-Aging Claims

Cosmetic Durability

Redness Reduction & Safety

OTC Claim Support

Moisturization Testing

Age Spots & Hyperpigmentation

Before & After Photography

Clinically Validated, High Resolution Before and After Images and Analysis Over Time. Validated Claim Support offers cutting-edge, high-resolution photography to help document product efficacy over a given treatment timeline or product usage cycle.

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