监管事务服务

您在欧洲的监管专家

通过专业的法规事务支持，让您的产品放心地进入市场。从战略到产品认证，我们提供量身定制的服务，以满足复杂的要求并达到欧洲标准。

无论是编制技术文件、管理档案资料，还是与监管机构协调，我们都能处理好细节问题，让您专注于创新。有 QbD 集团在您身边，您的企业就能保持合规性和竞争力。

了解我们的监管服务

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专业知识

对监管要求和行业挑战有深入了解的专业人员。

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量身定制

每个项目都是独一无二的，我们的方法也是如此。我们会根据您的目标、市场和时间表量身定制策略。

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始终保持最新

监管环境瞬息万变。我们将为您提供最新的见解和更新，确保您走在时代前沿。

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实地体验

具有丰富实地经验的顾问，包括电子提交。

市场趋势与挑战

监管环境不断变化，使得合规性比以往任何时候都更加复杂和重要。严格的欧盟法规要求精确和注重细节，对技术文档、标签和产品生命周期管理提出了更严格的要求。跟上这些变化的步伐对于避免延误和保持市场准入至关重要。

新兴技术 和创新产品（如组合疗法和医疗器械）进一步增加了监管流程的复杂性。要驾驭这些错综复杂的问题，需要专业的知识和积极主动的方法，以确保及时获得批准。

全球化 也增加了监管方面的挑战，公司需要管理多个市场的合规性。要在满足不同要求的同时保持竞争力，战略性的统一监管事务方法至关重要。

QbD 集团的法规事务专家可为您提供有效应对这些挑战所需的 洞察力和支持，确保合规性，使您能够及时将产品推向市场。

了解我们的服务

我们在以下领域提供监管事务服务

全部

RA Strategy for Pharma

Bringing your pharmaceuticals to the market requires a tailor-made strategy. We can help you to form that strategy and make it a success.

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Drug Development

New pharmaceuticals must be manufactured to high-quality standards before they can be placed on the market. We support you from drug discovery to pre-clinical and...

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Early Development

We can maximize your success by leveraging our expertise in regulatory consultations and strategic planning for First-in-Human trials.

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Scientific Advice

Seeking scientific advice or protocol assistance during drug development offers numerous benefits. Our regulatory experts can help you to interact with the required...

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Regulatory Procedures

There are various procedures to register pharmaceutical drugs, depending on the type of drug and your intended route to market. Our experts will lead you to the right...

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Submissions

Irrespective of the type of your regulatory procedure your applications for marketing authorization must be accompanied correctly by the required documentation. Our...

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eCTD Publishing

The skills needed to confidently compile electronic submissions can take years of training, industry immersion and regulatory study. Let us be your guide for electronic...

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Artwork & Labeling

Artwork and labeling play an important role in the marketing process of any pharmaceutical and are highly regulated. Our regulatory experts will help you to create...

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Lifecycle Management

Our experts will accompany you throughout the whole Product Life Cycle Management (PLM) process – from its conception, through design and manufacture, to service and...

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Information Officer

A qualified Information Officer from QbD Group can coordinate and monitor pharmaceutical organizations’ information management and marketing activities.

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Orphan Diseases

Rare diseases deserve just as much attention as more common diseases. We can support you in the development of medicines for patients suffering from rare diseases.

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Regulatory Intelligence

Regulations and standards may change every now and then, and manufacturers must be aware of those changes. Our consultants keep you on track at all times.

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RA Strategy for MD & IVD

Our tailored and strategic approach will help guide your organization through the complexities of regulatory frameworks, ensuring a smooth journey from development to...

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RA Design & Development

Embark on your journey by conceptualizing your IVD or MD. We will assist you in navigating the intricate landscape of design and development, ensuring that your product...

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Legal Representative

If the sponsor of a performance study is not established in the European Union, we can ensure that a natural or legal person is established in the Union as its legal...

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Technical Documentation

We can support the writing and compilation of IVDR/MDR-compliant technical documentation in line with your notified body’s specific expectations.

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Notified Body Submissions

Navigating the submission process can be daunting, but you don't have to do it alone. Our experts can prepare and submit your application to the notified body, ensuring...

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Post-Market Surveillance

Post-Market Surveillance (PMS) is a vital component of maintaining product safety and efficacy once your IVD/Medical Device is on the market. We will assist you in...

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Authorised Representative Services

If you want to sell your product in countries other than your own, it is important to consider the local regulations. Find out more about our in-country representative...

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Person Responsible for Regulatory Compliance (PRRC)

Are you looking for a person responsible for regulatory compliance (PRRC) for your IVDs of Medical Devices? We provide PRRC services to IVD/MD manufacturers with fewer...

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Authorized Representative (EC-REP)

Are you looking for an Authorized Representative (EC-REP) for your medical devices and/or IVDs?QbD Group, supported by the Qarad experts, is an independent partner that...

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Authorized Representative (CH-REP)

Are you looking for a Swiss Authorized Representative (CH-REP) for your medical devices and/or IVDs? Qarad Suisse S.A. – part of the QbD Group – is an independent...

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UK Responsible Person (UKRP)

Are you a medical device and/or IVD manufacturer based outside the UK, but selling in the UK? If so, you need aUK Responsible Person (UKRP). Qarad UK Ltd. – part of the...

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Linguistic Review

QbD Group offers expert linguistic review services to meet tight deadlines and regulatory requirements.

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Landing in Europe

Accelerate your entry into the European life sciences market with QbD Group's expert regulatory support, compliance solutions, and strategic guidance for seamless...

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IVDD to IVDR Transition Support

Get expert support for your IVDD to IVDR transition. From gap assessment to submission, QbD ensures a smooth, compliant path to certification.

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为什么选择 QbD 小组？

在 QbD 集团，我们不仅了解法规方面的挑战，我们还能解决这些挑战。凭借十多年的经验、全球网络和 600 多名专家组成的团队，我们为您的法规事务需求提供端到端的支持。

我们的与众不同之处

专业知识：对欧盟和全球监管框架的深入了解。
量身定制的战略：适合您的产品和市场的定制方法。
全球影响力：本地化洞察力与国际可扩展性。
主动更新：始终走在监管变化的前沿，确保您的合规性。

与 QbD 集团合作，简化合规流程，加速您的市场成功之路。

联系我们

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+10 年经验

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全生命周期支持

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全球业务

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最佳管理公司

最新见解

Webinar

PMS & PMCF Compliance for Medical Devices Under EU MDR

Gain practical insights on PMS & PMCF compliance for medical devices under EU MDR. Watch our webinars on demand.

Case study

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

QbD Group streamlines linguistic reviews for a leading pharma client, ensuring compliance and accuracy across 25 EU/EEA languages while meeting stringent regulatory deadlines.

Case study

Supporting Market Access to Essential Medicines in Europe

Support your entry into the European pharmaceutical market with expert regulatory guidance, ensuring compliance and access to essential medicines for patients. Contact us today for assistance.

Whitepaper

Medical Device Regulation (MDR) Checklist

Implement the Medical Device Regulation (MDR) with ease. Download our checklist of mandatory documents for MDR compliance.

Whitepaper

Regulatory Affairs for Pharma and Biotech

In this flyer, you will learn more about the regulatory services QbD Group provides for the pharmaceutical and biotechnology industries.

Whitepaper

Clinical Evaluation for Medical Devices under MDR

This whitepaper will guide you through crucial regulatory documents pertaining to the clinical evaluation process of your medical device. Download now!

Whitepaper

IVDR extension: what does this mean for you?

In this whitepaper, you will learn the impact of the IVDR transition extension and receive tips and strategies to navigate these regulatory changes.

Webinar

Drug-Device Combination Products and Article 117

Explore the regulatory complexities of Drug-Device Combination Products. Learn about Article 117 requirements, Notified Body Opinions, and more.

Whitepaper

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

This whitepaper will help you navigate the maze of the DTx regulatory environment, highlighting several important countries and regulations.

Whitepaper

Clinical investigations under MDR: key insights and practical experiences

This whitepaper covers clinical investigation authorization under MDR, the EU Legal Representative's role, and the MDR's impact on study conduct and post-market surveillance.

Case study

CE Mark Renewal for bioXtra Products: A Success Story

Discover how Lifestream Pharma successfully renewed the CE mark for their BioXtra Dry Mouth products under the EU MDR. Learn about the challenges faced, the approach taken for compliance, and the results achieved.

Webinar

Technical Documentation Essentials for Medical Device Software

Gain practical insights on crafting MDR-compliant technical documentation for Medical Device Software.

Webinar

Getting Started: Overcoming Initial Obstacles in Medical Device Software Development

Watch our webinar on demand and learn about regulatory obstacles, MDR, AI Act, and best practices for medical device software development and market entry.

Webinar

Mastering Clinical Performance Studies under IVDR

In the evolving regulatory landscape of IVDs, demonstrating clinical performance is more crucial and challenging than ever. Discover more in this webinar on demand.

Whitepaper

Clinical evidence for In Vitro Diagnostics under IVDR

In this whitepaper, we will guide you through the documents required for the demonstration of clinical evidence under the IVDR. Download now.

Webinar

Post-Market Surveillance Requirements for Medical Devices and IVDs

Learn about post-market surveillance requirements under MDR and IVDR regulations. Gain insights from industry experts in this on-demand webinar.

Whitepaper

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

Discover the key role of Regulatory Affairs in pharma and how Regulatory Affairs teams support product lifecycle management in this whitepaper. Download now.

Webinar

3D Printing in the Healthcare World

Explore the challenges and opportunities of 3D printing in healthcare, featuring expert insights on regulations, pitfalls, and efficiency.

Webinar

IVDR Extension Explained: Tips & Strategies

Gain valuable insights on the IVDR extension and its impact on IVD manufacturers with our webinar on demand.

Whitepaper

Innovations in ATMP: state of the industry in 2024

This whitepaper explores the innovations in ATMP and solutions in detail, with a focus on the current landscape as of April 2024. Download now.

Case study

The journey toward IVDR compliance for the LVOne device

QbD Group helped Upfront Diagnostics gain entry into the MD/IVD industry by supporting them on their path to ISO 13485 certification.

Case study

Ensuring a smooth MDR transition for Oystershell's medical devices

The landscape of medical device regulations is constantly evolving, making it a challenge for companies to keep up. Our collaboration with Oystershell, which began in July 2023, highlights our expertise in transforming complex challenges into success stories, all with a touch of QbD Clinical magic.

Case study

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

QbD Clinical assisted Minze Health, a urology-focused medical devices company, in obtaining CE marking under MDR through clinical evaluation.

Webinar

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

Learn about the Medical Device CE Certification Pathway, from classification to conformity assessment by a Notified Body. Join our webinar on demand.

Case study

Helping Relu to comply with changing regulations

QbD Group supported software company Relu with their expertise to comply with changing regulations.

Case study

Quickly bringing a new COVID-19 medical device to market

Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking.

发现所有

监管事务服务

您在欧洲的监管专家

专业知识

量身定制

始终保持最新

实地体验

市场趋势与挑战

我们在以下领域提供监管事务服务

RA Strategy for Pharma

Drug Development

Early Development

Scientific Advice

Regulatory Procedures

Submissions

eCTD Publishing

Artwork & Labeling

Lifecycle Management

Information Officer

Orphan Diseases

Regulatory Intelligence

RA Strategy for MD & IVD

RA Design & Development

Legal Representative

Technical Documentation

Notified Body Submissions

Post-Market Surveillance

Authorised Representative Services

Person Responsible for Regulatory Compliance (PRRC)

Authorized Representative (EC-REP)

Authorized Representative (CH-REP)

UK Responsible Person (UKRP)

Linguistic Review

Landing in Europe

IVDD to IVDR Transition Support

为什么选择 QbD 小组？

+10 年经验

全生命周期支持

全球业务

最佳管理公司

联系我们

最新见解

PMS & PMCF Compliance for Medical Devices Under EU MDR

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

Supporting Market Access to Essential Medicines in Europe

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