Regulatory Affairs | Our Services - QbD Group

Regulatory Affairs Services

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.

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Our offerings for Regulatory Affairs in Pharma & Biotech

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

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

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

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

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

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

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 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

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

Information Officer

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

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

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.

Linguistic Review

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

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...

Combination Products

Navigate the complex regulatory pathways for combination products in the EU and US with QbD Group's expert guidance and tailored support.

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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.