Public regulation is on the rise which requires many sectors to comply with detailed regulatory requirements, often harmonised at the European level. Thanks to years of experience, we are able to provide expert legal and advisory services in highly specialised fields. We often provide services within a broader advisory framework that includes transactional, grant, or strategic advice.
Our expert team has long been involved in various highly regulated areas of business, with an emphasis on regulation in the field of the environment, State Aid, the energy sector, public administration, real estate, pharmaceuticals, international sanctions, advertising, and banking.
How can we help you:
- We assist banks, insurance companies, payment institutions, consumer credit providers, and other financial institutions with the implementation of regulatory requirements affecting their business . Whether it be ensuring compliance of internal regulations and terms and conditions with sectoral regulation, introducing fit and proper procedures and remuneration, setting up outsourcing of certain activities to third parties, supporting payment security due diligence, or designing a new financial product.
- We assist FinTech clients with regulatory requirements impacting new technologies. These include blockchain, cryptocurrencies and other types of digital assets, biometrics, crowdfunding, and artificial intelligence. We handle communication with the regulator, obtaining the necessary licenses or setting up contractual relationships, and advise on other related areas, in particular data protection or consumer law.
- For transactions in the FSI sector, we help ensure the transaction runs smoothly from a regulatory perspective. We advise clients on how to structure a planned transaction to meet sector regulatory requirements, secure regulatory approvals, and focus on the post-transaction integration of financial products, distribution networks, and internal management and control systems of the financial entities involved in the transaction.
Energy Sector Regulation
- We will represent you in proceedings before the Energy Regulatory Office.
- We provide legal advice in the field of renewable energy, as well as in the production, distribution, or trading of energy commodities, including the preparation of the necessary contractual documentation.
- We advise on trading and handling emission allowances.
LSHC Sector Regulation
- We focus on advising on the public regulation of drugs, medical devices, dietary supplements, and the provision of health services. We provide legal support on regulatory and legal issues such as drug registration, clinical trials, manufacturing, and distribution of medicines, including the setting up of related contractual relationships, advertising regulation, and price regulation.
- We advise on regulatory compliance, including assisting with internal and external audits in the area of compliance with regulations (legal, internal, or ethical) governing the pharmaceutical industry.
- We represent clients in administrative proceedings; we provide support in the process of applying for manufacturing or distribution authorisations, as well as in proceedings concerning offenses such as price regulation, drug regulation, or regulation of the provision of health services.
Regulation of International Sanctions
- We advise on EU sanctions and other restrictive measures against Russia and Belarus in connection with the Russian aggression in Ukraine and other sanction regimes, in cooperation with customs and risk management experts.
- We will carry out thorough Environmental Due Diligence on your business or the business being purchased.
- We offer consultancy in the area of extended responsibility of producers when placing selected products on the market (product take-back) and waste management in general.
- We provide regulatory compliance advice on the marketing of products in terms of their compliance with harmonised product requirements in particular, such as product safety and eco-design requirements, related product labelling, and disclosure requirements.
- We can help you implement your corporate sustainability strategy and adapt your operations to the needs of the circular economy.
Real Estate Regulation
- We provide comprehensive legal support in permitting procedures for real estate projects.
- We provide comprehensive advisory services in the assessment of the impact of construction projects, integrated pollution prevention, and control or liability for damage and environmental damage.
- We set up appropriate coordination of activities with new ESG requirements, specifically in the real estate and construction sector, or with specific requirements for sustainable development by public authorities.
- We can assist you in the full breadth of construction law and related environmental regulations, such as environmental impact assessment (EIA), water regulations, or waste management.
Regulation of Administrative Proceedings
- We will represent you in all types of administrative proceedings and in proceedings before administrative courts and the Supreme Administrative Court.
- We provide legal advice, especially in price control, customs, environmental and health matters.
- We will represent you in litigation for compensation for damages caused by an unlawful decision or an incorrect official procedure.
Regulation of State Aid
- We will assess whether your company has a realistic chance of receiving a public subsidy.
- We will prepare notification forms of individual aid and assist you during the approval process.
- We will represent you before the Office for the Protection of Competition or the European Commission.
- We will prepare a restructuring plan in accordance with public subsidy rules.
- We will verify compliance with the conditions of already granted public subsidies for projects or activities implemented.