The term "partnership" has become a trendy word in the contract research organization (CRO) world. While it's meant to describe a close collaborative relationship between CRO and client, too many organizations claim to be partners when in reality they are only research sites or project-based consultants.
Nutrasource Blog
How to Form a CRO Partnership That Delivers Results
Posted by Josh Baisley, B.Sc., Vice President, Clinical Design & Delivery on Mon, Oct 15, 2018
Prop 65 Updates: How to Ensure Dietary Supplement Compliance in California
Posted by Kevin Yan, M.Sc., Director of Analytics & Certifications on Fri, Sep 07, 2018
In the wake of California's updated Prop 65 requirements—which came into force August 30, 2018—many of our clients have approached us with questions regarding compliance.
Tags: Product Testing & Certifications, Regulatory, Dietary Supplements/Natural Health Products
Substantiating Products With No Guidance: The CBD Confusion
Posted by Susan J. Hewlings, Ph.D., R.D., Director of Scientific Affairs on Fri, Aug 17, 2018
While many U.S. states (and, of course, Canada) are approving medical and recreational use of cannabis products, confusion about how these products are regulated continues to grow.
Tags: Claims, Regulatory, Cannabis
Implications of FDA's GRAS and NDIN Policy Changes for Supplements and Medical Foods
Posted by Dr. Richard Kraska, Ph.D., Chief Scientific Officer - GRAS Associates on Tue, Jul 24, 2018
Our regulatory affairs team has regular contact with the U.S. Food and Drug Administration (FDA) for a number of projects. Occasionally we learn about subtle policy shifts regarding Generally Recognized as Safe (GRAS) Notifications and New Dietary Ingredient Notifications (NDIN).
Below is an overview of FDA’s latest updates to GRAS and NDINs which will have important implications for the dietary supplement and medical foods industry in the U.S.
Tags: Regulatory, Dietary Supplements/Natural Health Products
Reverse-Engineering Your Regulatory Strategy for More Efficient Product Development
Posted by Josh Baisley, B.Sc., Vice President, Clinical Design & Delivery on Thu, Jul 12, 2018
Regulatory strategy is the backbone of successful product development. Brands that lack a clear regulatory plan at the beginning of the process can face longer times to market and potentially higher costs associated with re-work or failure.
Tags: Clinical Trials, Regulatory, Dietary Supplements/Natural Health Products
How Health Canada’s Upcoming Self-Care Product Regulations Could Impact Your Marketed Natural Health Products, Non-Prescription Drugs, and Cosmetics
Posted by Nutrasource on Wed, Jun 27, 2018
Tags: Product Marketing, Pharmaceuticals, Regulatory, Dietary Supplements/Natural Health Products
Choosing a contract research organization (CRO) is one of the most important steps in a dietary supplement research and development plan.
Tags: Clinical Trials, Regulatory, Dietary Supplements/Natural Health Products
5 Essential Tips for Substantiating Dietary Supplement Claims
Posted by Jennifer Andrews, M.Sc., MBA, Marketing Director on Mon, Jun 13, 2016
Product claims are a key component of dietary supplement positioning and marketing. Companies use claims to showcase their product's health effects, nutritional benefits or performance to reinforce brand values and help boost sales.
Substantiating product claims is an important aspect of any product launch or
repositioning strategy. Not having the right type or level of data required to support a
claim can put a brand at risk for regulatory consequences, negative publicity and,
ultimately, a loss of market share and competitive advantage.
Below are five essential tips and best practices from our Dietary Supplement Claims Substantiation E-Book which you can use to develop an effective claims strategy for your dietary supplement:
Tags: Product Marketing, Clinical Trials, Claims, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products
Taking an Integrated Clinical and Regulatory Approach for the Prebiotic/Probiotic Market
Posted by Jennifer Andrews, M.Sc., MBA, Marketing Director on Wed, Jan 27, 2016
Prebiotics and probiotics aren't going anywhere. In fact, this emerging market has become so popular in recent years that there are now two major events dedicated solely to prebiotics/probiotics. Here we take a look at one of the most challenging aspects of the research and development (R&D) process for companies looking to bring prebiotics/probiotics to market.
Tags: Clinical Trials, Pharmaceuticals, Regulatory, Foods & Beverages, Dietary Supplements/Natural Health Products
The 5 Key Questions to Ask Before Your Next Product Launch
Posted by Nutrasource on Thu, Jun 25, 2015
You have an exciting new product idea and are ready to take the leap and go to market. Before you start selling, however, it is important to make sure your product is the best it can be from a regulatory standpoint.
Tags: Claims, Regulatory, Concept to Claim, Dietary Supplements/Natural Health Products