Regulatory Support

At NutriMarketing we define and execute the required regulatory substantiation for your product, with an understanding of the increasing demanding and changing regulatory landscape common in this market. We ensure that all your materials comply with FDA, FTC and DSHEA requirements in the North American market. Our experts and legal advisors have in-depth experience into the nutraceutical and dietary supplement industry and we help our clients safely navigate U.S. food, dietary supplement, and cosmetic regulations.

 

New and changing global regulations have a major impact on the functional food and nutraceutical business and we'll help you to keep in step with changing regulations. The regulatory landscape has changed considerably over the last few years and much of this has been driven by harmonization both regional and global. Our experts have in-depth experience in the food and nutrition industries and are continuously in contact with the main regulatory bodies throughout the world. We follow closely the regulations in force for dietary supplements and functional foods in all key markets and understand regulations involving health claims. We can help you meet product regulatory requirements by providing scientific dossiers and insights into each country's regulatory guidelines.

 

Our partners are continuously analyzing all regulatory developments –in the European Union, Americas, Asian, LATAM and ASEAN markets. We adjust to every change that takes place in order to ensure full compliance and maximum global availability of your product and can advise at every step in the complex process of a multi country launch. We offer regulatory advice through all stages of the launch process including product development from concept to formulation to packaging, claims, and more. This high level and proactive approach on the front end of product launch process can save costly missteps with budget, time and resources.

 

Our regulatory experts can provide guidance and tactical execution for regulatory submission, country by country- including:

 

  •   Product registration for compounds and ingredients
  •   Label and advertising review
  •   Scientific dossier submission for claim approval and support
  •   GRAS substantiation
  •   Path to Market and Path to Claim strategy and guidance