Dossier Preparation

A regulatory dossier is a collection of relevant documentation and applications, registrations, or filings submitted for authorization or approval of a product to the responsible regulatory authority

Food supplement registrations in the European Union require new novel food product manufacturers to prepare a complete regulatory dossier in order to demonstrate that their products are safe for human consumption and that any claims they make are supported by evidence. It is also important to note that some member states in the European Union have differing requirements for registration and market authorization for Food Supplements.

For this reason, it is best to partner with a firm that can offer regulatory support tailored specifically to meet the requirements for each member state in the European Union.

dicentra provides the following services to help support the creation of your regulatory dossier

  • Preparation of safety dossiers
  • Preparation of efficacy dossiers to support health claims
  • Dossier submissions
  • Liaison with Responsible Regulatory Authority
  • Scientific literature review
  • Scientific and Medical Writing

Contact us to learn how our Food Supplement Regulatory Services can help get your products to market in the European Union