Substantiation Sciences

Substantiation Sciences is a United States-based scientific and regulatory consulting firm that positions itself as a provider of "science-based solutions from concept to market." According to its official website, the company serves the dietary supplement, food, beverage, medical foods, consumer packaged goods (CPG) and over-the-counter (OTC) pharmaceutical industries, as well as adjacent categories such as pet foods, botanical drugs and pharmaceuticals. Its stated mission is to empower clients' success through science-driven solutions, offering evidence-based strategies and expert regulatory guidance intended to help products thrive from early concept through commercial launch. The firm describes its work as consulting across all aspects of the research and development lifecycle. Its advertised service areas include claims substantiation dossiers, GRAS (Generally Recognized As Safe) and NDIN (New Dietary Ingredient Notification) gap analysis, scientific and technical writing and communications, expert opinion letters, research program and project management, preclinical and clinical program support, compliance assessments, and intellectual property assessment. A separate services page organizes offerings into categories such as scientific affairs, intellectual property, education and training, scientific communications, legal and compliance, corporate development, research and development, and marketing and media support. The company also promotes expert witness services, reflecting a practice that bridges nutrition science consulting and legal/regulatory support. Substantiation Sciences was co-founded by Dr. Susan Hewlings and Dr. Douglas S. Kalman. The company's website states that its team brings over 50 years of combined industry and academic experience. Dr. Hewlings is described as a scientist, researcher and educator with more than two decades of experience helping companies translate rigorous science into credible, compliant and market-ready health products; she specializes in scientific substantiation, regulatory strategy and research design for dietary supplements, functional foods, beverages and companion animal health products. She holds a PhD in Nutrition, an MS in Exercise Physiology and a BS in Nutrition from Florida State University, and is a Registered Dietitian. Dr. Kalman is identified by the post-nominal credentials PhD, RD, FACN, FISSN. The company is associated with the Florida Keys in the United States, according to its Wikidata entry, which describes it simply as a company in Florida Keys, United States. It operates primarily in the U.S. market and maintains an online presence through its website and LinkedIn. As a privately held professional services firm, it does not appear to be publicly listed. Its positioning is that of a specialist consultancy rather than a product manufacturer: it helps brands substantiate claims, navigate complex regulations and position products for success in competitive markets.

Substantiation Sciences is a U.S.-based scientific and regulatory consulting firm co-founded by Dr. Susan Hewlings and Dr. Douglas S. Kalman. The company's public materials describe a practice built around translating rigorous nutrition and regulatory science into credible, compliant and market-ready health products. Its website states that the team brings over 50 years of combined industry and academic experience, and it presents itself as bridging the gap between innovation and sales by helping clients turn ideas into market-ready solutions. From its founding, the firm has focused on the dietary supplement, food, beverage, medical food, CPG and OTC pharmaceutical industries, with additional reach into pet foods, botanical drugs and pharmaceuticals. Its service model spans the research and development lifecycle: ingredient evaluation, study design, claims development and regulatory positioning. Advertised capabilities include claims substantiation dossiers, GRAS and NDIN gap analysis, scientific and technical writing and communications, expert opinion letters, research program and project management, preclinical and clinical program support, compliance assessments and intellectual property assessment. A services page further organizes the practice into scientific affairs, intellectual property, education and training, scientific communications, legal and compliance, corporate development, research and development, and marketing and media support, and it promotes expert witness services. Dr. Hewlings is described as a scientist, researcher and educator with more than two decades of experience helping companies translate rigorous science into credible, compliant and market-ready health products. She specializes in scientific substantiation, regulatory strategy and research design for dietary supplements, functional foods, beverages and companion animal health products, and she holds a PhD in Nutrition, an MS in Exercise Physiology and a BS in Nutrition from Florida State University, and is a Registered Dietitian. Dr. Kalman is identified by the credentials PhD, RD, FACN, FISSN. The company is associated with the Florida Keys in the United States according to its Wikidata entry, which describes it simply as a company in Florida Keys, United States. It operates primarily in the U.S. market and maintains an online presence through its website and LinkedIn. As a privately held professional services firm, it does not appear to be publicly listed.

• Substantiation Sciences is co-founded by Dr. Susan Hewlings and Dr. Douglas S. Kalman.

• The firm markets claims substantiation, GRAS/NDIN gap analysis, scientific writing, expert opinion letters and expert witness services.

A specialist science and regulatory consultancy offering evidence-based, science-driven solutions from concept to market for supplement, food, beverage, medical food, CPG and OTC pharmaceutical clients.

• Claims substantiation dossiers

  Dossiers supporting product claims with scientific evidence.

• GRAS; NDIN; Gap Analysis

  Regulatory gap analysis for Generally Recognized As Safe and New Dietary Ingredient Notification pathways.

• Scientific & Technical Writing/Communications

  Scientific and technical writing and communications support.

• Expert Opinion Letters

  Expert opinion letters for regulatory and legal purposes.

• Research Program & Project Management

  Management of research programs and projects.

• Preclinical & Clinical Program Support

  Support for preclinical and clinical research programs.

• Compliance Assessments

  Assessments of regulatory compliance.

• Intellectual Property Assessment

  Assessment of intellectual property.

• Expert Witness Services

  Expert witness services for legal matters.

1. 1Substantiationsciences - Expert Witness, Nutrition Science Consultingsubstantiationsciences.com
2. 2Substantiationsciences - Substantiation, Science Writing, Dietary Supplement Consultingsubstantiationsciences.com
3. 3Expert Witness Services - Substantiationsciencessubstantiationsciences.com
4. 4Substantiation Sciences (United States) - Wikidatawikidata.org