Legal Representative - Regulatory Affairs - QbD Group (4)

Legal Representative Clinical Trials

For sponsors of performance studies based outside the European Union, appointing a legal representative within the Union is a regulatory requirement. This representative acts as the point of contact with EU authorities, ensuring that the study complies with local laws and regulations.

QbD Group can provide your study with the expertise needed to guide you through the regulatory landscape and ensure full compliance with EU requirements.

What is a legal representative?

A Legal Representative is an individual or legal entity established within the European Union that is designated to act on behalf of a non-EU sponsor for regulatory matters related to performance studies. This role is crucial for ensuring that performance studies meet the regulatory requirements set by the EU, including submission to National Competent Authorities and Ethics Committees.

Responsibilities of a legal representative

Communication with authorities: The legal representative serves as the official point of contact between the sponsor and EU regulatory bodies, such as the Competent Authorities and Ethics Committees.
Regulatory compliance: They ensure the study adheres to the European Union’s stringent regulatory framework, ensuring that all necessary notifications, authorizations, and amendments are handled in accordance with EU law.
Representation of the sponsor’s interests: The legal representative is responsible for ensuring that the sponsor's regulatory obligations are met, from initial study notifications to any necessary modifications and study termination.
Document submission: They manage the submission of required documentation, including those in compliance with Annex XIV and other relevant EU regulations.

How can we support

Legal Representative - Regulatory Affairs - QbD Group (3)

How we can support

Strategic guidance: We provide advice on regulatory requirements, study authorizations, and submission strategies.
Regulatory submissions: We assist with compiling necessary documentation for submission to Ethics Committees and Competent Authorities, ensuring all regulatory requirements are met.
Study amendments & modifications: We help navigate any changes or updates to your study, ensuring compliance with EU standards throughout.
Complete support: From pre-study planning to post-study activities, we offer full regulatory support to ensure smooth project execution.

Strategic guidance

Regulatory submissions

Study amendments & modifications

Complete support

Why partner with QbD Group?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS

Over 10 years of expertise: Our consultants bring a wealth of knowledge to ensure the success of your performance study.
End-to-end support: From initial planning to post-marketing phases, we provide comprehensive support for your study’s lifecycle.
Global network: With offices in Europe and South America, we are well-positioned to support international clients.
Commitment to client satisfaction: We focus on transparency, clear communication, and the successful execution of your regulatory needs.

Partner with QbD Group to ensure that your study complies with all regulatory requirements, allowing you to focus on advancing scientific discovery.

Legal Representative - Regulatory Affairs - QbD Group (1)

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Are you prepared to ensure compliance and effectively manage EU regulations with assurance?

Let us help you manage the complexities of performance study regulations. Reach out to connect with our expert team and get started today. We're here to guide you every step of the way.

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Discover all

Legal Representative Clinical Trials

What is a legal representative?

Responsibilities of a legal representative

How we can support

Strategic guidance

Regulatory submissions

Study amendments & modifications

Complete support

Why partner with QbD Group?

Related services

Companion diagnostics

Clinical solutions

Get in touch

Related content

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader​

Medical Device Regulation (MDR) Checklist

Regulatory Affairs for Pharma and Biotech

Clinical Evaluation for Medical Devices under MDR

IVDR extension: what does this mean for you?

Drug-Device Combination Products and Article 117

Mobile health on the rise: exploring the regulatory landscape for reimbursement

Clinical investigations under MDR: key insights and practical experiences

CE Mark Renewal for bioXtra Products: A Success Story

Technical Documentation Essentials for Medical Device Software

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Mastering Clinical Performance Studies under IVDR

Clinical evidence for In Vitro Diagnostics under IVDR

Post-Market Surveillance Requirements for Medical Devices and IVDs

The key role of Regulatory Affairs in the pharmaceutical industry: from drug development to commercialization

3D Printing in the Healthcare World

IVDR Extension Explained: Tips & Strategies

Innovations in ATMP: state of the industry in 2024

The journey toward IVDR compliance for the LVOne device

Ensuring a smooth MDR transition for Oystershell's medical devices

Successful clinical evaluation supports rapid CE marking of Minze Health's Uroflowmeter

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Helping Relu to comply with changing regulations

Quickly bringing a new COVID-19 medical device to market

A Decade of Excellence: Linguistic Review Support for a Global Pharma Leader