Regulatory Affairs

Manufacturers may encounter procedural obstacles when navigating the local Regulatory system for Food and Food Supplements product registration due to the fact that regulatory criteria vary between regions. In one country, foods and food supplements are categorized as dietary supplements, whilst in another, the Health Authority (HA) recognizes them as foods for special medical purposes. In such situations, the organization cannot afford a misunderstanding error. Whether it is to understand dossier requirements, claims, the list of forbidden substances, or import rules for their nutraceutical products, a business must be aware of all the relevant needs.
CEBIS delivers a worldwide Food and Food Supplements Regulatory Road map to assure compliance and has a proven track record of aiding customers with their expansion ambitions in the world’s rapidly expanding health food industries. CEBIS specializes in food product registration, compliance, licensing, approvals, notification, legal representation, Market Authorization Holder (MAH), License holding, Imports and distribution Regulatory guidance, food product marketing strategy, Regulatory pathways, and Regulatory strategies.

CEBIS services in regulatory affairs include the following:

Food Supplement product registration with the authorized authorities and notice of said registration.

Conformity Assessment and Formulation troubleshooting with an in-depth analysis of the product and its formulation, advising about whether it could be classified as a food supplement and which modifications it may need to do to comply with the applicable legislation; this service also includes an in-depth analysis of the product and its formulation.

Labeling Review, including product labels and packaging, as well as the creation of instruction documents that are simple to read in order to ensure compliance with labeling legislation.

Nutrition and Health Claims Analysis, including advice on how products can be legally marketed in accordance with the regulations of various nations and jurisdictions.

A review of advertising and marketing to ensure that it complies with advertising standards and codes.

The provision of scientific evidence to support the claims made about dietary supplements.

Prepare Novel Food applications, which call for a pre-market safety evaluation in the form of a Novel Food Application or the simplified method for’substantial equivalence’ foods. These applications are necessary because Novel Foods require a pre-market safety evaluation.

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CEBIS Interantional

Romania- Helios Business Center (HBC),
47 Bd. Theodor Pallady,
Bucharest, Romania