Case Study: Phase 1 Clinical Trial for a Botanical Product at the NHP/Controlled Substance Interface

January 05, 2023

Case Study: Phase 1 Clinical Trial for a Botanical Product at the NHP/Controlled Substance Interface

Download this case study to learn how Nutrasource worked with a Sponsor to conduct Phase 1 clinical trials of varying formulations to understand this botanical’s characteristics and potential efficacy for further natural health product (NHP)/dietary supplement (DS) development and/or pharmaceutical development.

Read More

Structure Function Claims Make Solnul™ the First Low Dose RS2

May 20, 2021

With a rapidly growing prebiotic market, companies are looking for innovative strategies to establish unique products. Download this case study to learn how Solnul™ has done just that by bringing back what they identified as an ancient source of starch to support a healthy microbiome.

Read More

A Strategic Regulatory Approach Achieves Novel Claims to Increase Market Share on Prebiotic Ingredient

September 04, 2019

Nutrasource achieves prebiotic claim on PreticX™, a xylooligosaccharide (XOS) from AIDP. Through combined thought leadership, AIDP was able to secure a Product License and novel claims while keeping their data packages proprietary.

Read More

Developing a Regulatory Strategy for Claims Substantiation Based on Risk for a Novel Natural Health Product

October 23, 2018

This case study provides an in-depth view of the thought process and strategies used by Nutrasource's clinical and regulatory teams to help one client support an aggressive claim (with Health Canada approval) for a one-of-a-kind cough suppression natural health product.

Read More

Complex Multi-Ingredient Products Can Be Effectively Studied to Ensure Optimal Dosing for Future Studies

July 18, 2018

Dietary supplement efficacy studies are often based on published literature of similar products, which fails to consider product-specific attributes. This produces ambiguous results that may not support the product claims, leading the Sponsor to lose a significant investment in time and costs. Find out how Nutrasource assisted a Sponsor in characterizing a dietary supplement using a Phase I clinical trial to determine appropriate dosing.

Read More

A Clinical Trial Investigating a Cough Suppressant Natural Health Product

July 18, 2018

Download this comprehensive case study to learn how Nutrasource's clinical and regulatory teams worked with one nutraceutical company to achieve regulatory approval and gain Canadian market entry with aggressive claims for a novel natural health product dosage form for cough suppression.

Read More

Third-Party Certifications as a Competitive Advantage

July 18, 2018

Download this case study to learn how our clients have leveraged Nutrasource's third-party certifications to enter new international markets, capture market share, and gain a competitive advantage on a global scale.

Read More

With Medrio, Nutrasource Proves the Value of Successful Data Management

July 18, 2018

Pre-market data management is an uncommon practice in the nutraceutical industry. Yet this lack of clinical data management stifles nutraceutical marketing by producing insufficient data quality to support product claims. This detailed case study explores the advantages of incorporating data management into nutraceutical development programs and provides specific guidance and resources for use of the Medrio data management system.

Read More

A Multi-Centre Clinical Trial to Determine the Efficacy of an Omega-3 Medical Food on Nutritional Deficiency in Non-Alcoholic Fatty Liver Disease (NAFLD) Patients

July 18, 2018

This case study provides a detailed overview of how Nutrasource assisted a Sponsor in gaining market access for an omega-3 medical food with a unique health claim focused on correcting nutritional deficiency in NAFLD patients.

Read More

Leveraging Nutrasource’s Integrated Regulatory and Clinical Research Approach to Gain Market Access for a Novel, Multi-Ingredient Natural Health Product for Breast Health

July 18, 2018

Successfully developing a new product from concept to claim requires an in-depth understanding of both regulatory and clinical research considerations. Download this case study to learn how Nutrasource's regulatory and clinical teams worked collaboratively to help one Sponsor gain Canadian market access for a novel natural health product with a competitive, one-of-a-kind claim pertaining to breast cancer risk mitigation.

Read More