Regulation and compliance play a vital role for most of our clients.
Working within Swiss, EU and global frameworks, we regularly advise on research, approvals, clinical trials, quality agreements, pricing, reimbursement and marketing, drug advertising, trans-border trade, compliance, investigations, regulatory due diligence and material benefits in the drug market.
Regulatory, Administrative Procedures and Compliance
The regulatory framework governing the life sciences sectors is complex and constantly evolving. Our specialized lawyers closely monitor the continuing regulatory developments and case law in this area.
Research and Development. Research and Development is a core issue in the life sciences sector. Our lawyers have extensive expertise in advising our clients in matters relating to their research and development projects. Swiss regulatory law is constantly changing. Our lawyers keep you up to date.
Approvals. Our regulatory experts are familiar with the modalities of the different types of approvals relevant in the life sciences sector and the particularities of the corresponding procedures. We assist our clients in the evaluation of the appropriate regulatory strategy and in the approval proceedings before the competent authorities (e.g. Swissmedic, Federal Office for Health, cantonal laboratories). We also represent our clients in procedures before the federal and cantonal administrative courts.
Clinical Trials. The regulation of clinical trials in Switzerland is somewhat different compared to that of the European Union. We have extensive experience in all legal issues pertaining to the conduct of clinical trials in Switzerland, including the drafting of the respective contractual arrangements.
Pricing and Reimbursement. We protect our clients' interests in administrative proceedings in pricing and re-imbursement matters before the Swiss regulatory authorities and represent our clients in court.
Drug Advertising. We are familiar with the restrictions applicable to drug advertising in Switzerland and assist companies in complying with the respective rules and represent companies in respective investigations by the regulator.
Transborder Trade. Transborder trade of pharmaceuticals into Switzerland is not only an issue under Swiss patent law but also under Swiss regulatory law. Transborder trade of food and near-food products into Switzerland as well is highly regulated and involves detailed knowledge of relevant law and practice. We are familiar with the legal modalities and closely observe the political and administrative developments in this field.
Compliance. Compliance is a challenge in the fast changing regulatory environment of the life sciences sector. We can help companies to produce and implement policies and processes to ensure that they follow the numerous laws, rules and regulations.
Material Benefits and Transparency in the Drug Market. We are familiar with the rules and regulator's practice regarding the restrictions applicable to promises and acceptance of material benefits as well as the transparency requirements in the drug market. We advise companies in respective compliance issues and support and represent them in investigations by the regulator.
Investigations. Our attorneys specializing in public law assist in regulatory proceedings. An important focus here is administrative procedures relating to the marketing of health care and food products. Our attorneys also assist in criminal proceedings against companies and individuals.