The past year was a whirlwind of regulatory change that brought exciting opportunities and new challenges in equal measure.
As we look to another game-changing year ahead, our regulatory and scientific team reviews the top regulatory trends expected to shape health product innovation and marketing in 2019 and beyond.
Here's what to expect...
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Tags:
Product Marketing,
Claims,
Regulatory,
Cannabis,
Foods & Beverages,
Dietary Supplements/Natural Health Products
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.
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Clinical Trials,
Regulatory,
Concept to Claim
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.
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Product Testing & Certifications,
Regulatory,
Dietary Supplements/Natural Health Products
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.
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Claims,
Regulatory,
Cannabis
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.
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Regulatory,
Dietary Supplements/Natural Health Products
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.
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Tags:
Clinical Trials,
Regulatory,
Dietary Supplements/Natural Health Products
New self-care product regulations are coming to Canada. Will your brand be ready?
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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.
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Clinical Trials,
Regulatory,
Dietary Supplements/Natural Health Products
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:
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Tags:
Product Marketing,
Clinical Trials,
Claims,
Regulatory,
Concept to Claim,
Dietary Supplements/Natural Health Products
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.
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Tags:
Clinical Trials,
Pharmaceuticals,
Regulatory,
Foods & Beverages,
Dietary Supplements/Natural Health Products