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Regulatory Affairs | Our Services - QbD Group

Regulatory Affairs Services

Your regulatory expert for pharmaceutical and biotech

Get your pharmaceutical or biotech product to market with confidence through expert Regulatory Affairs support. From strategy to product approval, we offer tailored services to navigate pharma and biotech regulations and meet international standards.
 
Whether it’s compiling marketing authorization dossiers, managing submissions, or coordinating with regulatory bodies, we handle the details so you can focus on innovation. Keep your pharma or biotech 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

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

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

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

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

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

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

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 & 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

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

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

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

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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Linguistic Review

Linguistic Review

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

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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Combination Products

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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Pharmacovigilance

Pharmacovigilance

QbD Group offers a full range of pharmacovigilance services to ensure your products meet compliance standards while safeguarding patient safety.
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The regulatory path in Pharma & Biotech is complex, but you don’t have to face it alone. Our specialists are ready to support you from early development to approval. Contact us today and ensure your therapies meet global compliance standards.
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