Regulatory and Quality Control Services for Food, Beverages and Dietary Supplements

Regulation and quality control of food, beverages, and dietary supplements are crucial to ensuring consumer safety, legal compliance, and product sustainability in increasingly competitive markets.

Unlike other sectors, the food industry demands a greater understanding of current legislation to ensure better comprehension and correct interpretation of regulations, criteria, and requirements of authorities, especially regarding positive lists of ingredients, additives, and processing aids, labeling, and post-market surveillance systems.

ELS Group acts as a technical-strategic partner in a wide range of regulatory and quality management services for food, beverages, and dietary supplements, supporting companies from initial regulatory compliance to ongoing compliance maintenance, with integrated operations in Europe and Latin America.

Present in 11 countries, with local teams and direct experience with regulatory authorities, ELS Group structures regulatory and quality solutions that allow for predictable product launches, reducing risks and enabling international operations.

ELS Group's comprehensive scope of Regulatory Affairs and Quality Control for Food, Beverages, and Dietary Supplements.

ELS Group’s expertise in regulatory affairs and quality control for food, beverages, and dietary supplements covers the entire production cycle, from initial assessment to production, launch, and marketing, including certification, scientific evaluation, labeling, and continuous monitoring.

Our work includes the following integrated and customized services:

  • Product regulation, including notifications of commencement of manufacturing and importation, notifications and registrations.
  • Regulatory framework and classification of products
  • Review of communication, notification, and registration processes.
  • Regulatory impact assessment
  • Preparation of dossiers for approval of the use of new ingredients, bioactive substances, probiotics, enzymes, etc.
  • Preparation of dossiers for obtaining GRAS Status
  • Drafting petitions for safety and efficacy assessments of new ingredients, novel foods, food additives, processing aids, enzymes, probiotics, etc.
  • Monitoring applications for approval and inclusion of new ingredients, food additives, and processing aids in positive lists with regulatory authorities in Europe and Latin America.
  • Review of toxicological studies to determine safety of use.
  • Guidelines for conducting toxicological studies
  • Review of clinical studies to determine efficacy in support of claims of functional and/or health properties.
  • Guidelines for conducting clinical studies
  • Assistance in the creation and maintenance of post-market monitoring systems (Nutrivigilance)
  • Registration renewal
  • Post-registration endorsements and changes
  • Drafting and reviewing labeling texts.
  • Review of label artwork and advertising materials.
  • Clarification of technical questions related to product communication.
  • Issuance of sanitary licenses and permits for companies.
  • DGAV Certifications
  • Free Sale Certificate for food supplements – DGAV
  • Certificate of Well-being – DGAV
  • Export Certificate – DGAV (Directorate-General for Food and Agriculture) expertise in import and export.
  • Registration of raw materials and ingredients of animal origin.
  • Strategic regulatory support
  • Gap Analysis of technical documentation
  • Drafting regulatory opinions
  • Preparation of feasibility reports for the regulatory approval of food, beverages, and dietary supplements.
  • Support in responding to technical requirements, notifications, and sanitary infractions.
  • Technical training on regulatory affairs

By integrating regulation and quality control of food, beverages, and dietary supplements into a single strategy, ELS Group enables companies to operate with greater regulatory predictability, food safety, and commercial stability in competitive markets.

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Frequently asked questions about regulation and quality control of food, beverages and dietary supplements.

It is the set of regulatory, technical, and quality activities that ensure that food, beverages, and dietary supplements meet the legal requirements for safety, composition, labeling, and communication established by the competent authorities.

It involves product classification, evaluation of ingredients, additives, processing aids, as well as any other substances, regulatory approval, post-market surveillance, and continuous maintenance of compliance.

From the initial stages of product development, defining the regulatory framework, evaluating ingredients, and developing a regulatory strategy must occur before the product is launched and remain active throughout its lifecycle, including renewals, changes, and post-market adjustments.

The regulatory framework defines which legal requirements apply to each product. An incorrect classification can result in rejections, technical requirements, product recalls, administrative sanctions, and delays in the production chain and product launches. Therefore, this analysis is a critical step in the regulatory strategy.

ELS Group operates internationally, with a presence in 11 countries, offering regulatory and quality support in Europe and Latin America.

The group has specialized local teams that work in an integrated manner with the main regulatory authorities in each region, allowing it to align global strategies with the specific regulatory requirements of each market.