Healthcare Law & Litigation. Doing what I know and love.
Their core legal issues – regulation, product liability, advertising, contracts, litigation – are my issues. Exactly these. With 25 years of experience in client practice at the highest international level. With expertise, speed, service and courage.
Regulatory
Advice
+
Drafting
Contracts
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Product Safety
& Liability
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Litigation &
Dispute Resolutio
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“Can-do solutions at the highest level.”
JUVE Handbook of Commercial Law Firms 2023/2024
Listen. Analyse. Act. That’s how I advise you.
I enjoy working closely with in-house legal counsel and specialist teams. I listen, I strive for solutions as a team player, I lead negotiations and represent clients in court. I do what makes you successful.
Dr Claudia Nawroth
- 1993–1998 Law Studies at Trier University
- 1998–2000 Doctoral thesis in the graduate programme “European Business Law”
- 2001 Doctorate (Dr iur.) at Heidelberg University
- 2000–2002 Legal clerkship and second state examination at the District Court Lübeck / Schleswig-Holstein
- 2002 Admission to the bar
- 2002–2007 Associate / Principal Associate with Freshfields Bruckhaus Deringer
- 2007 Qualification as specialist attorney for intellectual property rights (Fachanwalt)
- 2007–2024 Counsel with Clifford Chance
- 2024 Foundation of Nawroth-Legal in Düsseldorf
- Languages: German, English, French
Contact
The best way to discuss your particular issue is in person.
I guide you through the regulatory requirements throughout the entire product life cycle of medicinal products and medical devices – in a practical, clear and structured manner:
For development, approval or certification:
- Clinical trials and observational studies (including CTR and Medical Research Act) for medicinal products
- Marketing authorisation (EMA/BfArM), DCP and MRP procedures
- Compassionate use programmes, off-label use, no-label use
- Product demarcation and classification
- Conformity assessment procedures, testing, labelling and instructions for use of medical devices
In marketing and advertising:
- Labelling and advertising in accordance with the Medicinal Products Advertising Act, Law against Unfair Competition, Green Claims Regulation
- Legal attack and defence strategies for market launches
- Compliance and transparency obligations
In production and distribution:
- Regulatory requirements for production, distribution and logistics, e.g. the regulation on the manufacture of active pharmaceutical ingredients, Good Manufacturing Practices, Good Distribution Practices, Narcotics Act, environment, sustainability
With regard to digital health services and AI:
- E-Health requirements (e.g. telemedicine, digital health applications,, digital care applications)
- Use of artificial intelligence in the healthcare sector
From practice I know how to draft and review industry-specific contracts – always embracing new and atypical constellations:
- for clinical trials, e.g. with CROs, investigators, trial centres, for R&D cooperations or grants
- for the marketing of medicinal products, including co-marketing, co-promotion, sponsoring and use of speakers
- for production and distribution, e.g. for contract manufacturing, co-distribution, direct sales to group purchasing organisations and clinics, logistics, quality assurance and delimitation of responsibilities
- defining and organising regulatory tasks and functions within the group
- M&A transactions and restructurings, including pharma-specific TSAs (temporary contract manufacturing, development, distribution, pharmacovigilance)
- in cooperations with – or provision of services to – states, government agencies and institutions
I advise you on legal requirements, assess risks, support you in crisis situations, support your communication as well as organisational measures and defend you against claims:
- Requirements of the EU Product Liability Directive and the EU Product Safety Regulation
- Product risks before market entry and measures in case of product safety reports
- Fulfilment of instructions and warning duties
- Communication, preparation and execution of product recalls
- Procedures and decision-making processes for product recalls
- Defence against claims for damages, support in disclosure procedures according to Section 84a German Pharmaceuticals Act
- Handling of serial damage and communication with third parties
- in advertising law and competition law disputes
- against product liability claims for medicinal products and medical devices
- in regulatory disputes with licensing and supervisory authorities
- in Government liability proceedings
- in contractual disputes
NAWROTH
Healthcare Law & Litigation
Girardet Haus
Königsallee 27
40212 Düsseldorf
Germany