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Legal advice that supports your team and strengthens internal capability — in complex international environments.

  • Legal and compliance advice for global R&D activities and clinical trials, with a strong focus on inspection readiness.

    Includes:

    • Global clinical trials legal frameworks

    • Clinical Research Organizations (CROs) and clinical vendors

    • Clinical sites and investigator relationships

    • Informed consent and patient interactions

    • Health Authorities, Institutional Review Boards (IRBs) and Ethics Committees

    • Pharmacovigilance and drug safety

    • Regulatory interfaces, inspections and audits

    • Early and Expanded Access Programs (EAPs)

    • Risk awareness and control frameworks

    • Legal and bioethical framework for the adoption and implementation of AI solutions

  • Legal advice on privacy, data protection, AI and digital innovation, with specialized expertise in the context of R&D.

    Includes:

    • Design global privacy programs

    • Data privacy in clinical trials and research collaborations

    • Data Protection Impact Assessments (DPIAs), data mapping, AI legal assessments and international data transfers

    • AI governance and digital solution assessments

    • Policy frameworks and legal assessments

  • Design, implementation and enhancement of global compliance frameworks aligned with business realities.

    Includes:

    • Compliance strategy and gap analysis

    • Codes of Conduct, policies, SOPs and guidance

    • Third-party risk mitigation

    • Tailored compliance training

    • Compliance Program enhancement and audits

  • Strategic legal support designed to strengthen internal legal and compliance capabilities.

    Includes:

    • Knowledge transfer and internal capability building

    • Tools, templates, playbooks and roadmaps

    • Proactive legal advice and early risk identification

    • Coaching on internal stakeholder communication

    • Process optimization

    • Reducing dependence on external legal advice

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References

  • "I had the pleasure of working with Magalie in R&D, Privacy and AI matters. She is an exceptional lawyer who combines strong legal expertise with a clear understanding of business priorities and operational realities. She has a remarkable ability to translate complex legal topics into clear, practical guidance that teams can readily apply. A highly professional, collaborative, and trusted partner who provides both strategic and tactical value; working with Magalie is always a pleasure.”

    Miquel Torrebadella

    Global Legal Lead AI Governance Data Protection and Digital Strategy at Alnylam Pharmaceuticals

  • “Working with Magalie - a legal and compliance consultant with deep prior in-house biotech/pharma experience - means tackling daily challenges with a trusted ally by your side. She truly gets the regulatory pressures, clinical trial deadlines, and commercialization pace, turning unique insider wisdom into refreshingly pragmatic, hands-on help.”

    Arianna Greco

    Senior Vice President and General Counsel for Research and Development and Commercial at Alnylam Pharmaceuticals

  • “I have exchanged with Magalie on numerous occasions across a wide range of topics, as she is a recognized expert in R&D and Clinical matters. Notably, she has established an annual conference that is widely regarded as one of the best in the industry. Through these conferences, Magalie consistently demonstrates a deep command of the most critical and emerging issues in the field, and an exceptional ability to mobilize her network to ensure that clients and peers receive timely, relevant, and practical insights. She combines a forward-looking perspective with a strong sense of pragmatism, an open mind, and a clear can-do attitude, while remaining highly attentive to new trends. It is a genuine pleasure to work with Magalie and to exchange ideas with her.”

    Anne de la Fortelle

    Associate General Counsel and Executive Director at Amgen Europe

  • „Magalie is an exceptional lawyer with a deep and well‑rounded understanding of business needs and the practical challenges that teams face. She has supported Novartis across a broad range of R&D legal topics, including leading the development of a consistent Global Consent Form that both protects the company’s interests and upholds patients’ rights. Her ability to translate complex legal issues into clear, actionable guidance tailored to real business realities is truly remarkable. Working with Magalie is consistently a pleasure, as she brings professionalism, insight, and a collaborative spirit to every interaction.“

    Sarah Bergues-Lang

    Head of R&D Legal, Global Medical Affairs, Safety & Quality at Novartis

  • „What I appreciate most about working with Magalie is the way she effortlessly turns complexity into clear, actionable guidance. After many years in the industry, my focus is on solution-oriented advice that balances risk, efficiency, and the realities of the business. Magalie not only understands what her clients truly need but also interprets the legal landscape through a pragmatic real‑world lens that consistently leads to confident, informed decisions.“

    Chris Carolan

    VP, Legal - Head of Contracts Management, Data Privacy & Insurance at Monte Rosa Therapeutics

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Sometimes it takes only one phone call

In just one focused conversation, you will gain the clarity, strategic direction and risk awareness that protects months of work. Let us address it together.

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