Life Sciences

We support:

• pharmaceutical, biotechnology, and veterinary companies,
• manufacturers, importers, and distributors of medical devices and IVDs,
• companies in the nicotine and tobacco industries,
• entities in the food, cosmetics, and chemical sectors,
• developers of digital technologies, AI, and data-driven solutions for healthcare.

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Our Approach

Our interdisciplinary team combines regulatory expertise with expertise in transactions, processes, taxation, public procurement, compliance, and white-collar crime. This enables us to support clients at every stage of the product lifecycle:

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R&D → clinical trials → registration → market entry → advertising → oversight → disputes and proceedings.

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We deliver solutions that are precise, practical, and actionable—we understand both the regulations and the realities of business.

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How can we help?

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Pharmaceuticals and Biotechnology

We provide consulting services at every stage of the life cycle of medicinal products:

• registrations, amendments, renewals, parallel imports
• data exclusivity, market exclusivity, patents, and SPCs
• GMP, DPD, FMD Directive
• market access / public funding.

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Distribution and Wholesale

We support pharmaceutical wholesalers in:

• obtaining and maintaining licenses
• GMP compliance and supply chain oversight
• GIF inspections and proceedings
• combating counterfeit drugs
• export restrictions and reverse distribution.

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Healthcare Law and Health Protection

We provide comprehensive support to healthcare facilities and medical service providers:

• market entry strategies and registrations
• regulations and operating models
• processing of medical data
• implementation of digital technologies and AI.

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Clinical Trials

We serve sponsors, CROs, and research sites. We specialize in:

• preparing and negotiating CTAs, ICFs, and SOPs
• managing changes during a trial
• transaction advisory services in the clinical research sector (M&A, site integration).

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Medical Devices and IVD

We provide comprehensive support across the full spectrum of MDR, IVDR, and national regulatory requirements:

• conformity assessment, CE marking, classification, transition periods, and legacy devices
• SaMD, AI in medical devices, and combined products
• proceedings before the URPL,
• counterfeit devices
• procedures for aesthetic medicine.

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Food Law

We support food manufacturers, distributors, and marketplaces:

• ingredient lists, labels, nutrition and health claims
• novel foods, foods for special dietary uses
• GI/PDO, dietary supplements, and GIS notifications
• disputes, inspections, recalls, and product liability.

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Veterinary Medicine

We provide consulting services in the following areas:

• licensing (including for psychotropic drugs and the National Atomic Energy Agency)
• compliance of documentation and advertising
• feed distribution chains, labeling, and B2C communication.

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Cosmetics and detergents

We provide assistance with:

• product classification (cosmetic/therapeutic/medical/biocidal)
• CPNP, PIF, safety assessment, SUE
• marketing claims and procedures before regulatory authorities.

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Nicotine and tobacco products

In a rapidly changing market, we provide support in:

• building distribution systems
• product labeling
• dealing with inspections by regulatory authorities (BDSC, MZ) and in proceedings before regulatory authorities and courts
• the legislative process and the evaluation of proposed regulations.

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AI and Digital Technologies

We advise developers and implementers of healthcare technologies on the following areas:

• regulatory classification of products
• GDPR and the processing of medical data
• IT contracts and patient data processing models
• AI in healthcare
• implementation of cloud solutions for the public and private sectors.

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Product Safety (GPSR)

We help organizations adapt to new requirements regarding:

• market surveillance
• supply chain and documentation
• e-commerce platforms.

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Advertising and Promotion of Regulated Products

• We review materials and campaigns.
• We draft contracts with HCPs.
• We provide advice on digital and influencer marketing.
• We represent clients in disputes regarding the advertising and promotion of regulated products.

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White-Collar Crime and Compliance in Healthcare

• We develop and implement compliance programs.
• We conduct internal investigations.
• We provide advice on compliance with national laws, the FCPA, and the UK Bribery Act.

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Disputes and Legal Proceedings

We represent clients in:

• regulatory, intellectual property, commercial, and patent disputes (SPC, Bolar, skinny label)
• disputes involving trademarks, trade secrets, and competition
• proceedings before the GIF, GIS, URPL, MZ, and IW
• domestic and international arbitration.

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M&A, Corporate, and Restructuring

We advise on regulatory-sensitive transactions:

• mergers, acquisitions, joint ventures, and spin-offs
• regulatory due diligence
• the impact of inspections on permits and registrations—optimization of transaction structures
• comprehensive tax support (transaction advisory services and representation before regulatory authorities and courts).

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Public Affairs and Legislation

We help you participate in the legislative process:

• we monitor regulations
• we prepare position statements and opinions
• we represent you in consultations and develop industry standards.