Helping clients navigate pharma- and medtech regulatory environments, negotiate complex contracts and solve disputes.
Comprehensive life sciences legal support, building on nearly two decades experience in working with in-house legal departments, corporate, compliance, commercial and R&D teams in multinational pharmaceutical and medtech companies.
Ad hoc, project & topic-specific support as well as interim and long-term mandates, serving as senior legal counsel, general counsel and member of executive teams.
Fair and flexible pricing.
Comprehensive life sciences legal support, building on nearly two decades experience in working with in-house legal departments, corporate, compliance, commercial and R&D teams in multinational pharmaceutical and medtech companies.
Ad hoc, project & topic-specific support as well as interim and long-term mandates, serving as senior legal counsel, general counsel and member of executive teams.
Fair and flexible pricing.
Filling internal positions and additional resource needs temporarily, for example in
cases of parental-/sick leave, specific projects, investigations or large work volume –
I am used to ‘hitting the ground running’ and integrate in internal organisations with ease.
Project examples: EMEA R&D Senior Legal Counsel (5y+) providing internal
operational legal support on EMEA R&D topics, including negotiation of R&D contracts,
Country Compliance Manager (8m – parental leave), temporary General Counsel
(2m), litigation support in major case (1y).
Skilled negotiator with solid experience in drafting, reviewing and negotiating all types
of life sciences relevant contracts, such as clinical trial-, research-, material transfer-,
services-, distribution-, licensing-, research-, collaboration-, and consortium agreements.
Project examples: COVIDRIVE / idDRIVE public private partnership consortium
agreement(s), complex R&D and licensing agreements, including
clinical trial agreements.
Comprehensive legal advice on the life sciences regulatory environment on topics such as data strategy, real world evidence, data science, AI,
IP, regulatory data protection, biosimilars, product qualification, clinical trials, privacy,
digital activities.
Project examples: Regulatory pathways identification EU & US, classification of
medical software SaMD / SaaS, legal advice on EMA qualification of novel
technologies, legal input to and drafting of global data strategy and AI and machine
learning policy, legal advice on privacy and use of AI in clinical trials and real world
evidence (RWE) projects.
Legal and operational support and development, implementation, review and update
of policies, directives, guidelines and SOPs, healthcare and corporate compliance
trainings.
Project examples: Development of data / RWE / scientific credibility / AI and
machine learning policies, directives and SOPs on interactions with healthcare
professionals / patient organisations, product promotion, medical education, medical
information, disease awareness, grants / charitable donations, scientific publications,
anti-corruption, competition law / antitrust compliance and related trainings, interim
country compliance manager for Switzerland.
Legal and project support, including analysis of new legislative proposals,
coordinating and consolidating company feedback to consultations, representation in
industry association working groups.
Project examples: Company representation in the European Federation of
Pharmaceutical Industries and Associations (EFPIA) in working groups on selected
regulatory topics, review of and comments to the EU data governance
and AI acts and EC trade policy, inception impact assessment for the legislative
framework for the governance of Common European Data Spaces.
Deal mediation, litigation and arbitration support for life sciences companies and law
firms.
Independent arbitrator, tribunal secretary, legal expert, co-counsel or shadow counsel in life sciences commercial and investment treaty arbitration cases.
Supporting in-house legal teams in managing contentious disputes, facilitating collaboration with external counsel while maintaining cost efficiency.
