Many industry sectors are heavily regulated, and it is critical for businesses ability to operate not just to be compliant but to develop compliance strategies that give them a competitive advantage. First hand knowledge and experience from relevant sectors is important when advising in these areas.
Understanding the legal aspects of regulatory pharmaceutical law is critical to obtaining the necessary authorisations for placing and keeping medicinal products on the market.
We have in-depth knowledge of regulatory law and practice and of the cooperation between the competent authorities within the EEA, as well as the European Commission and the European Medicines Agency. Our practice also covers national and EU-regulatory requirements on pricing and reimbursement of medicinal products, on advertising and on the regulatory requirements applicable to wholesalers and pharmacies.
Our experience from both the public sector as well as from advising pharmaceutical companies is important when providing assistance in the pharmaceutical field.
The food and beverage industries are also strictly regulated, with regard to the content of the products, their safety, their labelling and marketing. We have first hand experience, including experience from the industry, in handling regulatory matters relating to food and beverages, but also representing clients vis-á-vis regulatory authorities and in litigation.
The travel industry is regulated i.a. with regard to service providers’ marketing to consumers, and with regard to the provision of credit. Providing legal advice in this area of the law requires particular attention to the multijurisdictional aspects of the provision of travel services, as services are generally provided over the Internet. We have assisted service providers in this sector for many years and have helped them stay compliant.
We assist companies across all sectors in their compliance with duties under the current data protection regulations, and assist businesses in adapting to the new requirements laid down in the EU General Data Protection Regulation (GDPR). We assist our clients with audits of their own and third parties’ processing of personal data, in the form of customer data and other data relating to natural persons, and with taking the necessary measures to ensure that such processing is lawful. Our TMT expertise means that we have a keen understanding of the technology used by our clients, and the data protection measures that clients can implement.