We develop strategic and practical solutions.
We advise pharmaceutical companies on all legal issues connected with the regulatory classification of a product as a pharmaceutical (in comparison to medical devices, cosmetics and dietary supplements, for example), on national and European approval procedures, on the renewal of approvals as well as variations and extensions to them and on regulatory data and market exclusivity.
This includes experienced consulting in the fields of paediatric regulation, orphan drug regulation and advanced therapies regulation. In the course of these activities we frequently act on behalf of our clients before national and European regulatory authorities and bodies, assist with their corporate in-house coordination and planning, and assert the rights of our clients before the appropriate courts. Another of our law firm’s focal points is the safety of pharmaceuticals (pharmacovigilance).
In connection with this, we assist with the implementation of, and compliance with, the strict national and European standards by ensuring that correct and functional corporate in-house processes and decision-making bodies are in place. We also provide support during the preparation stage and offer guidance within the framework of official inspections as well as referral and step-by-step planning procedures. This also includes liability issues under civil and criminal law. At the interface to benefit assessment and the reimbursement of costs, we work hand in hand with other experienced law firms.
Medical Devices Law
Given the number and diversity of the medical devices on the market, dispensing legal advice to manufacturers of medical devices requires broad experience both in relation to the interplay of national and European standards, and with regard to the requirements of technical documentation and the influence of international standards (technical norms).
Our law firm guides small and medium-sized enterprises as well as large medical device manufacturers and research institutions in the following areas: development and testing of medical devices, correct classification as a medical device (in comparison to in-vitro diagnostic products, software or accessories, for example), implementation of the required conformity assessment procedure and CE marking, product information design (labelling and operating instructions) and the marketability of product combinations (e. g. advanced therapies).
We assist our clients in their cooperation with national and European authorities and committees and with Notified Bodies, as well as asserting their rights in court. Market surveillance and the implementation of corrective measures (CAPA) are as much a part of our expertise as contesting product liability claims.
The protection of personal data plays a significant role in the development and marketing of medicinal products and medical devices – and not only ever since the application of the General Data Protection Regulation (GDPR). We advise pharmaceutical and medical devices companies as well as medical research institutions on data protection issues under the GDPR and relevant national data protection laws on a regular basis.
The assessment of data privacy/data protection aspects is an integral part of our consulting services, in particular when advising clients concerning the implementation of clinical research projects or in connection with the marketing of personalized medicine. In that regard, we have built significant experience concerning the classification of data protection responsibilities, the development of data protection information and informed consent forms for study patients and study staff, and data protection issues related to pharmacovigilance/vigilance, biobanking and the transmission of personal data (e.g. to third countries).
In addition, we assist our clients in drafting data protection contracts/agreements and with respect to data protection questions concerning the organisational structures required under the GDPR, as well as the dealing with data subjects’ rights and data breaches.
One of our law firm’s specialist fields is compliance with the statutory requirements when pharmaceuticals and medical devices are tested on human beings. We have many years of experience in the implementation of clinical trials with pharmaceuticals and medical devices and with the realisation of other biomedical research projects involving human beings.
There are ethical, medical and legal boundaries, which must be observed (in particular, good clinical practice – GCP), checked and approved by competent authorities and ethics committees. Our expertise encompasses all forms of cooperation within the framework of clinical research in academic institutions and with investigators and study centres, sponsors, contract manufacturers and contract research organisations (CROs).
One focal point of our advisory activities concerns contract management between the respective cooperation partners (investigator contracts, CRO contracts, manufacturing contracts, subsidy and cooperation agreements) in German and English.
These days, giving legal advice to companies, institutions and individuals in the healthcare system would be unthinkable without comprehensive expertise in the field of healthcare compliance.
We ensure that our clients comply with all regulations and conduct recommendations relating to anti-corruption and healthcare by drafting or reviewing in-house guidelines (standard operating procedures, SOPs) or contractual agreements relating to various forms of cooperation and by training the staff regularly on the basis of the latest training documents.
We assist our clients not only internally, but also externally in their legally legitimate cooperation with medical institutions, doctors and healthcare professionals.
Product Promotion Law
The promotion of pharmaceuticals and medical devices is strictly regulated by law in many countries and the subject of wide-ranging legal proceedings under unfair competition acts. Our law firm can draw on many years’ experience in the field of product promotion law (Law on Advertising in the Healthcare System – HWG) and in legal disputes involving unfair competition laws (Unfair Competition Act – UWG).
We review product information and promotional material for our clients in order to avert potential complaints about aspects relating to product promotion law (e. g. prohibition of off-label-use advertising or advertising for prescription-only pharmaceuticals, bans on advertising to the general public, provision of misleading information about product attributes) and help to structure this information.
As a result, companies regularly integrate us into their internal approval processes. We act both in and out of court for our clients in antitrust proceedings. Another of our focal points in this area is the regulatory classification of a product as a pharmaceutical, medical device, cosmetics product or dietary supplement within the framework of unfair competition proceedings.
For our clients we manage and review all types of contracts that relate to the development, testing, manufacturing, marketing and sale of pharmaceuticals and medical devices.
Our competence lies particularly in the specific fields of contract management for clinical trials (investigator contracts, CRO contracts, IIT contracts, cooperation and subsidy agreements), contract manufacturing and contract testing agreements, OEM contracts, pharmacovigilance agreements and cooperation agreements in the healthcare compliance area.
We have a broad spectrum of practical expertise and, by arrangement with our clients, draft model contracts and bi- or multilateral contracts in line with specific requirements. Our expertise encompasses not only contract management, but also the successful negotiation of contracts at national and international level.
Transactions entered into by pharmaceutical companies and medical device manufacturers require intensive preparation and competent handling. Thanks to our long-standing regulatory expertise, we are regularly involved in companies’ transactions either in our own right or as a team member in conjunction with law firms specialising in the M&A field.
Our law firm advises its clients on the regulatory assessment of pharmaceutical approvals and CE markings, including the impact of ongoing proceedings, cooperation agreements and product safety aspects (vigilance). We conduct these assessments within the framework of regulatory due diligence both nationally and internationally and can draw on a network of internationally acknowledged experts.
Our activities encompass all preparatory measures (e. g. preparation of check lists), the assessment in the data room and the creation of a final report on the findings of the regulatory assessment
not just with a law firm"
23552 Lübeck / Germany
F +49 451 31 70 260 - 10