{"id":9836,"date":"2026-04-10T15:53:55","date_gmt":"2026-04-10T14:53:55","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/consulting-services-for-the-pharmaceutical-industry\/regulatory-services-and-quality-management\/regulacao-e-controle-de-qualidade-de-medicamentos\/"},"modified":"2026-04-15T17:36:30","modified_gmt":"2026-04-15T16:36:30","slug":"regulation-and-quality-control-of-medicines","status":"publish","type":"page","link":"https:\/\/els-solutions.com\/en\/consulting-services-for-the-pharmaceutical-industry\/regulatory-services-and-quality-management\/regulation-and-quality-control-of-medicines\/","title":{"rendered":"Regula\u00e7\u00e3o e Controle de Qualidade de Medicamentos"},"content":{"rendered":"\t\t
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Regulatory Affairs Services\nand
Quality Control of pharmaceutical products<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Who We Are <\/h2><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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ELS Group brings together a team of highly specialized professionals with proven experience in regulatory frameworks and compliance in the pharmaceutical sector. We position ourselves as a strategic partner from administration to technical management, ensuring rigor, consistency, and predictability in driving critical decisions and mitigating regulatory risk.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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What do we guarantee? <\/h2><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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Our company provides comprehensive support in regulatory affairs, Quality Control (QC), and pharmacovigilance. This support aims to reduce regulatory risk and enhance the success of commercial operations in strategically selected markets by defining a regulatory strategy and the most appropriate authorization pathway. The authorization process includes the structuring and detailed review of the Marketing Authorization application and its subsequent commercialization. Post-marketing lifecycle management, including variations, renewals, and ongoing compliance maintenance, is conducted rigorously and consistently. We also ensure compliance in QC, as well as drug labeling and information, guaranteeing adherence to regulatory safety obligations through robust documentation, traceability, and deadline management standards in a highly regulated environment.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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Where do we operate? <\/h2><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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We have a presence in 11 countries, operating directly in Europe and Latin America, with a special focus on Portugal and Brazil, where we have an operational presence. We operate in complex and highly regulated environments, ensuring technical consistency across jurisdictions and continuous alignment with national authorities.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t

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When do we intervene? <\/h2><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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ELS Group is present at every stage of the product lifecycle, from market access to the post-marketing phase. In this context, important decisions are made regarding positioning and continuity in strategic markets, maintaining authorizations and marketing conditions, preventing supply disruptions, and, above all, reducing the risk of non-compliance. These measures have a direct impact on operations and commercial performance. The team supports, with the same level of rigor, every stakeholder in the pharmaceutical value chain \u2013 manufacturers, distributors, importers\/exporters, quality control laboratories, and logistics partners \u2013 as well as all operators who, in practice, ensure product continuity and compliance up to market.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Full scope of Regulatory Affairs and Quality Control Services for pharmaceutical products.<\/h2>\t\t\t\t<\/div>\n\t\t
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Pharmaceutical product registration<\/div>\t\t\t\t<\/div>\n\t\t\t\t
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Active substance (API or IFA), intermediate of the active substance and materials used in its preparation, or medicinal product (finished product): <\/div><\/span>\n\t\t\t\t\t\t\t\n\t\t\t<\/path><\/svg><\/span>\n\t\t\t<\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t
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