Regulatory & R&D
Understanding the European regulatory framework is of crucial importance for companies that wish to successfully establish their products on the European market. Based on our vast experience and high degree of specialization in the life sciences and healthcare sector, we can support our clients in a tailor-made way and at the highest level. We advise our clients on the broad field of regulatory requirements and strategies throughout the entire life cycle of their products, beginning with early clinical development, marketing authorizations, product safety up to variations and pharmacovigilance.
For the benefit of our clients we closely monitor the on-going changes in the regulatory framework for life sciences and quickly adapt to new developments. Our team is strongly engaged in the legislation process of new legal regimes. This enables us to spot important upcoming changes in the regulatory field with possible impacts on our clients’ interests at the earliest possible stage (see Public Policy & Governmental Affairs).
Our services particularly include:
- Comprehensive advise on clinical trials, in particular contractual arrangements between the various partners (investigator contracts, CRO contracts, funding and cooperation agreements with IIS ), correspondence with national and European authorities, preparation and evaluation of Informed Consents , labeling , manufacturing and reimbursement of investigational medicinal product / medical device
- Legal advice on all aspects of the EU Clinical Trial Regulation (CTR), such as the application procedure, the practical implementation of co-sponsoring, communication with ethics committees, dealing with negative (now standardized) decisions by the higher federal authority, possible avenues of appeal, questions regarding the digitalisation of clinical trials (e.g. remote monitoring), conflicting data protection regulations between CTR and GDPR, as well as the obligation of sponsors to register and publish study results and the protection of sensitive data
- Demarcation between the various types of products in the healthcare sector (i.e. pharmaceuticals, medical devices, ATMP, combination products, cosmetics, food, dietary supplements, biocides, plant protection products, etc.)
- Legal and strategic advice on the authorisation of medicinal products in Europe. Our expertise includes both the centralised procedure at the European Medicines Agency (EMA) and the national German market authorisation procedure, as well as DCP and MRP procedures
- Advising medical device companies in implementation questions concerning the new Medical Device Regulation (MDR), the development and testing of medical devices, the classification as a medical device, carrying out the conformity assessment procedure, the design of product information (labeling and instructions for use) and the marketability of combination products (eg. Advanced Therapies)
- Advice on the regulatory requirements for the manufacturing, sales and distribution of pharmaceutical products, medical devices, food supplements, cosmetics, biocides, plant protection products as well as other chemicals in Europe
- Legal advice on labeling issues of pharmaceutical products,medical devices, food supplements, cosmetics, biocides, plant protection products as well as other chemicals
- Legal advice in connection with audits of competent authorities and regulatory Third – party audits (i.e. notified bodies)
- Advice on obtaining manufacturing and wholesale licenses
- Holistic advice on pharmacovigilance and medical devices vigilance issues (see also product safety)
- Legal advice on and preparation of regulatory contracts such as contract manufacturing agreements, responsibility demarcation agreements, co-development, co-promotion and co-marketing agreements, etc. (see also Contracts)
- Regulatory advice and due diligence in the context of M&A transactions (see also Healthcare M & A)
Advice on public procurement law
Since 2006 the German generic market is mainly driven by tenders of individual health insurances such as the AOK group (approx. 40 % market share) which are governed by EU public procurement law. The company succeeding in tenders obtains superiority at the pharmacy dispensing point (generic substitution) and thus usually gains volume. Even though various forms of tenders exist (one or three partner models / open house contracts) a solid knowledge about the provisions on generic substitution and procurement law are crucial to succeed in tenders and gain market share.
Our service includes the detailed legal and strategic advice regarding tendering procedures of public insurances and hospitals for medicinal products and medical devices. We support our clients in the negotiation and public procurement processes for rebate contracts with various payer groups as well as in the legal processes at the German award chambers.