Pharmaceutical Law and Life Sciences

Regulatory requirements and compliance

  • Preservation and maintenance of regulatory approval
  • Naming and labelling of pharmaceutical and medicinal products
  • Classification of medicinal products and conformity assessment
  • Advice on questions of delimitation in the field of pharmaceutical products, medicinal products, foodstuff and cosmetics
  • Sponsoring and collaboration with patient organizations, contracts with pharmaceutical representatives, hospitals and doctors, advice on anti-corruption measures in the health sector


Agreements in the product development and marketing stage

  • Drafting in and outlicensing agreements, agreements with CROs for clinical trials, NDAs 
  • Drafting agreements for development cooperations, contract manufacturing agreements and agreements for the delimitation of responsibilities, pharmacovigilance agreements, co-marketing and co-promotion agreements, transfer of rights in products, granting shared dealings rights


Intellectual property rights and infringements

  • Pharmaceutical and life sciences patents as well as patent infringement and nullity proceedings
  • Supplementary protection certificates (SPC), regulatory exclusivity, registration data protection (RDP), exclusivity of orphan drugs and pediatric rewards
  • Pharmaceutical and medicinal product trademarks and designs 
  • Parallel imports and re-imports


Advertising and marketing

  • Advising on the requirements under the law on advertising medical remedies, misleading advertising, advertising non-approved medicinal products and off-label use
  • Advising on impermissible benefits and rebates
  • Representation in litigation regarding the law on advertising medical remedies


Data protection

  • Advising in all questions relating to data protection in the health sector, in particular in relation to patient data, apps, hospital information systems, digital patient records as well as use of health data for therapeutic purposes (personalized medicine)
     

 
Our further consulting services: