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OTC Ingredient Pilot Studies

Active Ingredients and Drug Concentration Claim Support Studies

Let Us Validate Your Next Custom Active Study

Over The Counter (OTC) products and actives should be tested only in an FDA Registered Facility within the US, and Validated Claim Support is proud to have registered with the FDA before we opened our doors. VCS was last inspected in August 2020, and our current registration can be found here:

If you are using regulated active ingredients, it is imperative that you follow posted rules and guidelines, and it is often recommended that you go above and beyond basic cosmetic safety testing practices.

Active ingredients such as Retinol are known to have some irritating properties, and irritants must be treated with an additional standard of care.

Common Over The Counter Ingredient claim support studies include:

Institutional Review Board for Drug Product Testing

We generally recommend that studies involving known irritants or OTC level ingredients are submitted to Institutional Review Board (IRB). IRB review allows us to get a full third-party safety review for the product and its intended use.

VCS maintains a relationship with Allendale IRB and IntegReview IRB, and we are happy to work with any other third-party IRB that the sponsor prefers.

Allendale IRB (Regulatory and Technical Associates)

Regulatory and Technical Associates, Inc. (RTA) is a toxicology, preclinical drug and medical device development, and regulatory affairs consulting company that specializes in a wide range of development activities. Our consultants are Board Certified in toxicology, regulatory affairs, and safety and have years of experience in toxicology, preclinical drug and medical device development, and regulatory affairs. We work with domestic and international clients and provide superior consulting services.

We focus our attention on the needs of our clients in the pharmaceutical, medical device, cosmetic, food, consumer product, chemical, and petroleum industries. We are recognized as a leading expert in women’s reproductive health and are registered as a US Agent with the FDA.
Our toxicology, preclinical drug and medical device development, and regulatory activities focus on the safety evaluation of new and established products. RTA has the necessary experience in toxicology, preclinical drug development, and regulatory affairs to assist our clients’ address the product development safety and regulatory issues that directly impact their ability to bring their products to market.

RTA routinely prepares regulatory submissions for the FDA and other worldwide regulatory agencies. These include INDs, IND Annual Reports, NDAs, CTDs, IDEs, 510(k)s, and PMAs, Food Additive Petitions, and GRAS determinations.

Drug and medical device product development is a rigorous, labor-intensive, and time-consuming process. RTA provides you with the experience, support, and consultation in toxicology, preclinical drug and medical device development, and regulatory affairs necessary to bring your products to market.

Advarra (formerly IntegReview)

With Advarra’s One-Touch Collaboration, your research team benefits from an outstanding service experience, a single point of contact, and consistent reviews from our integrated, single IRB. It is our goal to proactively facilitate your study experience and deliver unmatched support. Benefits include:

  • One central point of contact who knows you and your study(ies)
  • One stream of clear, coordinated communications
  • One study startup process for all sites, whether an institution or an independent research site
  • One set of forms, processes, and document templates for clear document management

Unlike other IRBs, Advarra offers a truly single IRB review and delivers white-glove service to our clients. We also guarantee an outstanding, streamlined process from submission to final documentation.

Typically, Advarra can perform a full board review of a new protocol and informed consent for a multisite trial within 4 business days. Expedited review of a new minimal risk protocol and informed consent can be completed within 2 business days or even less depending on the urgency of your need. Advarra also provides rush review services to help you meet demanding timelines. As your partner, Advarra is committed to getting your trial started on time and helping you reach critical study milestones quickly.

Pilot Studies and Preliminary Efficacy for Topical Drugs

For preliminary active ingredient studies, sometimes sponsors are still “honing in” on the most optimal active concentration for consumer use. In these cases, VCS often recommends a pilot study on 5-10 subjects where we will be able to review the different concentrations directly in comparison to one another.

This isn’t always possible for facial application or long-term products, however, it is a very powerful and cost-effective way to begin your journey into claim support, and it can provide quite a robust set of comparison-related information.

For final claim support studies, VCS recommends completing the study with a minimum of 30 subjects for statistical significance. This number is also the widely accepted industry standard.

Validated can also provide Clinical Photography on subsets of as few as 5 subjects to help demonstrate novel Active ingredient Efficacy.


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