Esche Schümann Commichau

Pharma & Life Sciences

Regulatory Requirements

Advising on all aspects of the drug approval process with particular emphasis on the legal requirements of clinical trials, European and national conditions for getting drugs on the market; selecting the proper approval data and obtaining and maintaining marketing authorization; compliance with pharmacovigilance duties; risk management programs, enforcement and inspection; advising on the classification and conformity assessment of medical devices; advising on delimitation questions involving the areas of drugs, medical devices, foods, and cosmetics.

Contracts in the Product Development and Marketing Stage

Drafting in- and outlicensing agreements, agreements with CROs for clinical trials, NDAs, agreements for development cooperation, contract manufacturing and delimitation of accountability, pharmacovigilance agreements, co-marketing and co-promotion agreements, transfer of rights in products, granting shared dealing rights.

Intellectual Property and Infringements

Advice and representation in relation to patents and patent infringement and nullity procedures, supplementary protection certificates (SPC), regulatory exclusivity, registration data protection (RDP), exclusivity of orphan drugs and pediatric rewards; advising on, researching, filing and defending drug and medical device brands and designs and representing clients in infringement proceedings; advice and representation in relation to parallel imports and re-imports.

Advertising and Marketing

Advising on the legal requirements to be respected in advertising drugs and medical devices and on the regulatory requirements concerning drug names, labeling and advertising; sponsoring and cooperating with patients organizations, contracts with speakers, hospitals and medical professionals, representing clients before the FSA; anti-corruption advice in the health care sector.

Data Protection

Advising on all aspects of data protection in the healthcare sector with particular emphasis on cloud computing and outsourcing patient and social data, telemedicine, mobile devices and health apps, launching hospital information systems, digital patient records and electronic health cards and using health data for therapy (personalized healthcare).

Product Liability

Representing clients in product liability proceedings.