Regulatory law is a branch of public law that regulates the actions of administrative authorities in specific economic sectors considered to be of strategic interest.
These sectors, such as energy, telecommunications, healthcare, transportation, the environment, and financial services, are subject to intensive regulatory intervention by states in order to ensure safety, fair competition, and consumer protection.
Companies operating in regulated sectors must first obtain specific authorizations or licenses from the competent authorities. These entities supervise compliance with the necessary legal and technical requirements to start or continue business operations.
The activities of companies are subject to controls and audits by regulatory authorities. Some of the most relevant agencies include the CNMC (National Commission for Markets and Competition), the EMA (European Medicines Agency), the DGCCRF in France (General Directorate for Competition, Consumption and Fraud Control), and the FSMA in Belgium (Financial Services and Markets Authority). We provide preventive compliance advice, helping to minimize legal and sanction risks.
We act as legal and technical intermediaries before regulatory bodies or national authorities. We draft letters, legal reports, and administrative appeals to defend your rights against unjust or disproportionate decisions.
Companies can participate — directly or indirectly — in the process of norm creation. We advise on submitting objections, participating in public consultations or technical committees, and following legislative initiatives in the Official Journal of the European Union or national bulletins.
In highly regulated sectors such as pharmaceuticals, food, or cosmetics, it is essential to comply with notification, authorization, or product registration procedures before commercialization. Additionally, mechanisms for monitoring, such as pharmacovigilance, traceability, or market withdrawal and alert management, must be established. Our team offers specialized legal advice on interactions with competent authorities, such as the EMA (European Medicines Agency).
When an administrative authority denies a license, imposes sanctions, or unjustifiably restricts economic activity, judicial appeal is essential. Our team represents companies, organizations, and public entities in administrative litigation procedures related to regulatory law, whether at the national or European level.
We have extensive experience in challenging administrative acts, appealing sanctions, and defending judicially against regulatory restrictions affecting business activity. We assist our clients through all phases of the process, from the administrative stage to defense in the courts.
Regulatory law directly impacts strategic sectors, where compliance is crucial for operating without interruptions or sanctions. This legal framework is especially relevant for:
In all these cases, a proper regulatory compliance strategy also protects the reputation and continuity of business activities.
At Arthur & Marín, we offer specialized legal assistance in regulatory law, including:
Legal feasibility studies for projects in regulated sectors.
Processing of administrative authorizations and permits.
Defense in sanctioning procedures and inspections.
Advice on public aid, rates, public tenders, and public sector contracts.
Regulatory consultancy and legal compliance in various sectors.
Representation before national authorities and European institutions, such as CNMC, AEMPS, CNMV, European Commission, EMA, ACER, BEREC, with direct communication and technical-legal defense.
Our experience spans from large multinational pharmaceutical companies to tech startups operating in regulated sectors
We have advised on cases before regulatory authorities, managed product notifications with the EMA, and defended our clients’ interests before European institutions, with international experience.
A legal reform or a new European directive can completely alter a company’s operational framework. We offer regulatory monitoring services that allow companies to anticipate regulatory changes, adapt in time, and make informed decisions. This includes legislative tracking in the OJUE, monthly regulatory alerts, and sector impact analysis.
We combine knowledge of regulatory law with extensive experience in European Union law, enabling us to offer cross-cutting advice tailored to the requirements of both regulatory levels.
Additionally, we represent our clients before European authorities and institutions, ensuring the defense of their interests.
When a company seeks to operate in new European markets, it must understand not only the EU’s common legislation but also the regulatory peculiarities of each member state.
We assist foreign companies in establishing operations in other EU countries or outside the EU, ensuring compliance with national and European regulatory authorities from day one.
We prepare clear, precise, and case-specific legal reports that analyze legal risks, interpret current regulations, and provide practical solutions in regulatory law.
If you operate in a regulated environment, having a specialized legal report is the best way to make informed decisions.
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At Arthur & Marín, we provide specialized advice with a national, European, and international focus, bringing clarity on regulations and legal compliance. Request a professional consultation with our team and discover how to turn regulatory compliance into a real advantage
info@arthurmarin.com
+32 465 34 53 45
