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Regulatory Affairs | Our Services - QbD Group

Your regulatory expert in Europe

Get your product to market with confidence through expert Regulatory Affairs support. From strategy to product approval, we offer tailored services to navigate complex requirements and meet European standards.
 
Whether it’s compiling technical files, managing dossiers, or coordinating with regulatory bodies, we handle the details so you can focus on innovation. Keep your business compliant and competitive with QbD Group by your side.

Expertise

Dedicated professionals with an in-depth understanding of regulatory requirements and industry challenges.

Tailor-made

Every project is unique, and so is our approach. We customize strategies to suit your goals, market, and timelines.

Always up to date

Regulatory landscapes evolve fast. We ensure you’re ahead of the curve with the latest insights and updates.

 

Field experience

Consultants with extensive field experience, including electronic submissions.

Market trends & challenges

The regulatory landscape is constantly evolving, making compliance more complex and critical than ever. Tightened EU regulations demand precision and attention to detail, with stricter requirements for technical documentation, labeling, and product lifecycle management. Keeping pace with these changes is essential for avoiding delays and maintaining market access.
 
Emerging technologies and innovative products, such as combination therapies and medical devices, add further layers of complexity to regulatory processes. Navigating these intricacies requires specialized expertise and a proactive approach to ensure timely approvals.
 
Globalization also increases regulatory challenges, with companies needing to manage compliance across multiple markets. A strategic, unified approach to regulatory affairs is vital for staying competitive while meeting diverse requirements.
 
QbD Group’s Regulatory Affairs experts provide the insight and support you need to navigate these challenges effectively, ensuring compliance and empowering you to bring products to market without delays.
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Our offerings for Regulatory Affairs in

RA Strategy for Pharma

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.
Drug Development

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...
Early Development

Early Development

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

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...
Regulatory Procedures

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...
Submissions

Submissions

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

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...
Artwork & Labeling

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...
Lifecycle Management

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...
Combination Products

Combination Products

Navigate the complex process of registering combination products in both the European Union (EU) and the United States (US).
Information Officer

Information Officer

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

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.
Regulatory Intelligence

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.
RA Strategy for MD & IVD

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...
RA Design & Development

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...
Legal Representative

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...
Technical Documentation

Technical Documentation

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

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...
Post-Market Surveillance

Post-Market Surveillance

Post-Market Surveillance (PMS) is a vital component of maintaining product safety and efficacy once your IVD is on the market. We will assist you in developing a...
In-country Representative Services

In-country 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...
Person Responsible for Regulatory Compliance (PRRC)

Person Responsible for Regulatory Compliance (PRRC)

Are you looking for a person responsible for regulatory compliance (PRRC) for your IVDs? We provide PRRC services to IVD manufacturers with fewer than 50 employees who...
Authorized Representative (EC-REP)

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...
Authorized Representative (CH-REP)

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...
UK Responsible Person (UKRP)

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...

Why QbD Group?

At QbD Group, we don’t just understand regulatory challenges—we solve them. With over a decade of experience, a global network, and a team of +600 experts, we offer end-to-end support for your Regulatory Affairs needs.

What sets us apart?

  • Specialized expertise: Deep knowledge of EU and global regulatory frameworks.

  • Tailored strategies: Customized approaches that fit your product and market.

  • Global reach: Localized insights with international scalability.

  • Proactive updates: Always ahead of regulatory changes to keep you compliant.

Partner with QbD Group to simplify compliance and accelerate your journey to market success.

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+10 years of experience

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Full lifecycle support

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Global presence

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Best Managed Company

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Get in touch

Navigating complex regulatory landscapes can be challenging but you don’t have to do it alone. Our experts are here to guide you every step of the way. Get in touch today and let’s ensure your products meet global compliance requirements.
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