The Microbiome Journey: Development of a Drug Product
In a wide range of therapeutic areas, recent studies have highlighted the link between microbial imbalance (dysbiosis) and the development…
The Microbiome Journey: Development of a Food Product with Health Claims
The microbiome and its relationship to the maintenance of health is a topic that continues to gain more and more…
Microbiome health products: drugs or foods?
Considerations on the development of pharmaceuticals and foods designed to favourably impact the human microbiome – health claims, legislation and…
Nutraceuticals and functional food regulations in key emerging markets
Nutritionals & Nutraceuticals describe the group of products occupying the grey zone between food and medicines and having recognisable health…
What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products?
What are the need-to-know characteristics of regulatory, nonclinical and clinical specific to microbiome products? A translational perspective Regulatory environment for…
Overcoming Regulatory and CMC Technical Challenges of Microbiome Product Development
In this white paper we provide a fleeting look at some of the CMC ‘building blocks’ that can be assembled…