Pakdaman Consulting, Inc.

Claims Substantiation Services

Pakdaman Consulting offers a full suite of research and literature services, including claims substantiation. This includes the following:

  • Comprehensive review of the totality of evidence regarding each ingredient of the assigned product, with particular focus on the concepts surrounding anticipated claims.

  • Review of published literature, utilizing several databases including, but are not limited to: pubmed.gov, MEDLINE, EMBASE, FDA submissions, US Patent Directory, medical textbooks, the Natural Medicine Comprehensive Database, the Cochrane Collaborative Database, as well as from reference lists of the acquired manuscripts.

  • Generation of evidence tables aimed at representing the physiologic processes related to each ingredient. One table will be made per ingredient.

  • Analysis of the tables and insight on the totality of evidence behind an ingredient as it relates to physiologic processes. From this analysis, substantiated scientific statements are generated that are believed to represent an accurate summary of this evidence.

  • Substantiated scientific statements generate from the evidence tables are then used to either substantiate existing claims or, in conjunction with client’s marketing team, to help generate new product claims.

  • Of note, full substantiation of a claim is best at the dose level. Thus the client is encouraged to provide the dose levels for all ingredients in the product, including proprietary blends. All proprietary formulations are subject to the attached nondisclosure agreement.

  • Deliverables include the following:

    • 1. Data tables, one for each ingredient.

    • 2. Summary of substantiated statements, including references of articles included in data tables.

    • 3. Claims summary, linking claims to substantiated statements.

    • 4. All original reference text used in literature review and substantiation will be provided to client as part of the deliverable package.

 

Timeliness Guarantee

We strive to complete all projects in a timely manner. Each type of project comes with a guarantee of completion date with discounts for project completion delays.

The timeline for completion of the claims substantiation document depends on the number of ingredients and claims evaluated. Typical product ingredient reviews include 3-5 ingredients and 2-3 claims. These projects typically have  turnaround time of thirty (30) calendar days.

If there is a delay in completion, then you will be credit with a discount of $50 for each day beyond the original deadline.

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