Regulatory

Many companies must comply with a number of different rules and regulations in order to be able to sell their products and services. At Delphi, we have broad experience in many different regulated industries. This has provided us with tools to help our clients with both legal and practical considerations in order to conduct their business in a safe and efficient way.

These regulatory requirements often originate from EU law. The requirements may concern rules for placing products on the market, registration or permits for a certain type of business, CE marking and other labelling requirements, pricing of pharmaceuticals and medical devices, clinical trials, marketing authorisations and substitution of pharmaceuticals, confidentiality issues etc.

For example, we assist our clients in the preparations for new launches, in situations where a product’s classification is questioned, an authority intends to enact a sales ban or when there are concerns about the labelling. Furthermore, during a due diligence our clients may need to verify that the business is conducted in accordance with applicable regulatory requirements. We help you analyse how a certain regulatory framework will affect inter alia the daily operations, safety or necessitate certain investments.

Preventative measures are important, and we offer tailor-made compliance programs and trainings to ensure compliance with EU law and other regulatory requirements.

In case an authority questions the actions of the company, we represent our clients in contacts with the authorities and in court proceedings. Additionally, we can provide expert advice in related issues such as competition law, public procurement, state aid, free movement and anti-corruption. We work closely with colleagues in other specialist areas at Delphi to handle questions concerning data protection, trade secrets, mergers & acquisitions, intellectual property rights, disputes and more.

We can assist with ad hoc issues as well as provide complex comprehensive solutions. We also have special regulatory expertise in life science, including pharmaceuticals, medical devices, cosmetics and healthcare, as well as foods, consumer goods, waste management, transports, telecommunications and the energy sector.