Legal Representative Services

Your Trusted Partner for Legal Representation in EU, the UK, and Switzerland

We provide Legal Representative services for non-EU sponsors (pharmaceutical and medical device companies) who do not have a registered office in the EU / EEA, or Switzerland. By partnering with us, you benefit from our expertise, ensuring regulatory compliance and efficient clinical trial conduct while minimizing administrative burden.

Why Do Study Sponsors Need a Legal Representative?

European Union / European Economic Area (EU/EEA)

Sponsors of clinical trials who are not established in the EU/EEA are required to appoint a legal representative based in an EU/EEA Member State to conduct clinical trials in the region.

Legal basis:

• Article 74 of the EU Clinical Trials Regulation (CTR) 536/2014
• Article 62 of the EU Medical Device Regulation (MDR) 2017/745

The Legal Representative may be located in any EEA Member State, regardless of where the trial is conducted.

EU countries

Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden.

The European Economic Area (EEA)

Includes all EU countries, plus Iceland, Liechtenstein and Norway.

The United Kingdom (UK)

Sponsor conducting a clinical trial in the UK must be established in the UK or an EU/EEA Member State. If this is not the case, then the sponsor must appoint a legal representative who is so established.

Legal basis:

• UK Clinical Trials of Investigational Medicinal Products (CTIMPs) Regulation
• UK Medical Device Regulation

Switzerland

Sponsors not established in Switzerland has to assign a representative based in Switzerland. This representative of the sponsor for a clinical trial serves as the contact point for the Swiss authorities and ethics committees when communicating with the sponsor.

Legal basis:

• Swiss Ordinance on clinical trials with the exception of clinical investigation with medical devices
• Swiss Ordinance on Clinical Trials with Medical Devices

What Does a Legal Representative Do?

A Legal Representative ensures that the sponsor complies with all regulatory requirements and acts as the official point of contact for regulatory authorities and ethics committees.

Key Responsibilities:

• Ensuring compliance with the applicable regulation
• Acting as the formal addressee for all regulatory communications
• Serving as the contact point for the Swiss authorities and ethics committees when communicating with the sponsor.
• Supporting regulatory submissions and interactions with authorities
• Facilitating smooth communication with ethics committees and competent authorities

Note: Some EU Member States may only require a sponsor to appoint a local contact person rather than a full legal representative.

What We Offer

Through our clinical operations, quality and legal representative services, we provide sponsors with seamless access to the European market.

Our Services

• Legal representation for non-EU sponsors
• Point of contact for regulatory authorities, ethics committees, and other relevant authorities

We Provide:

• Regulatory framework analysis
• Guidance on clinical trial compliance and strategy
• Support for regulatory submissions
• Oversight of clinical trial conduct and compliance
• Direct representation of the sponsor

We Assure:

• Compliance with regulations and Good Clinical Practice (GCP)
• Accurate and timely regulatory reporting
• Seamless interactions with local authorities and ethics committees
• Confidentiality and professional integrity

Why Partner with Us?

• 20+ years of expertise in conducting global clinical trials (pharmaceutical and medical device)
• Up-to-date knowledge of the European & Swiss regulatory frameworks and industry best practices
• Time and Cost-effective solutions – experienced consultant-based service instead of a large organization (e.g., CRO)
• Commitment to client satisfaction and excellence