Pharmaceutical law
- Advising a pharmaceutical company on reimbursement issues for a cancer drug (among others early benefit assessment according to AMNOG)
- Consulting of pharmaceutical companies for the implementation of the so-called Good Practice Standards (GLP, GMP, GCP, GDP)
- Preparation of an expert opinion for a Swiss pharmaceutical company on the interpretation of a supplier agreement in the pharmaceutical sector and claims to be derived therefrom in the context of a dispute with a distribution partner
- Advice of a Japanese pharmaceutical company on contract manufacturing, testing and quality assurance agreements, distribution agreements, pharmacovigilance and safety exchange agreements as well as on transport agreements
- Advice of various US companies on Marketing Authorisation Applicant Agreements.
- Advise of various pharmaceutical companies on the use of compassionate use schemes and orphan drugs in Germany.
- Conduct of a due diligence under pharmaceutical law within the scope of the planned purchase of a biobank
- Pharmaceutical and regulatory due diligence in the context of a bidding process for a German manufacturer of active ingredients and chemicals (Novacap)
- Advice on regulatory, contractual and IP issues as part of the due diligence process in the exclusive bidding process for the acquisition of a well-known omega-3 product manufacturer
- Advice of a US pharmaceutical company on the effects of the Drug Counterfeiting Directive and practical implementation recommendations
- Regular advice and legal representation of pharmaceutical companies in the field of medicinal products advertising and unfair competition law
- Advice of a private equity investor on certain legal aspects relating to the applicability of the Pharmacy Operating Regulations (ApBetrO)
- Regular advice of pharmaceutical companies on contract manufacturing and quality assurance agreements, cooperation agreements as well as trademark and patent licensing agreements
- Advice of various pharmaceutical companies on price regulations in the pharmaceutical industry for prescription and OTC products, also in connection with cross-border constellations
- Advice of various pharmaceutical companies on the content of a corporate.com platform from the perspective of medicinal products advertising law
- Advising a Swedish pharmaceutical company in the context of a transaction on specific issues relating to orphan drug authorisation.
- Regulatory, contractual and IP due diligence and related issues in connection with a capital increase for a pharmaceutical company specialising in haematology, clinical immunology and intensive care medicine.
- Regulatory and contractual due diligence for an international pharmaceutical company in the context of a bidding process for the OTC portfolio of a well-known pharmaceutical company.
- Regulatory, contractual and IP due diligence in connection with the proposed acquisition of a global life science company providing products and services to accelerate the development and commercialization of small molecules.