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Drug Development - Regulatory Affairs - QbD Group

Drug Development

New pharmaceuticals are required to be manufactured to high quality standards before they can be placed on the market.

We support your from drug discovery to pre-clinical and clinical testing. 

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What is drug development?

From discovery to market: Drug Discovery ⟶ Pre-Clinical ⟶ Clinical Testing

 

Drug development entails drug discovery, pre-clinical and clinical testing. New chemical entities (NCE) need to show minimum standards of safety, toxicity, pharmacokinetics and metabolism in animals (pre-clinical testing) and humans (clinical testing) and be manufactured to high quality standards before they can be placed on the market. 
 
The drug development process is a very lengthy (up to 10 years) and costly (costs for NCEs can run into several millions of Euros) business. Only few NCEs pass all the lengthy testing and make it to the market. 
 
To ensure marketability, drug development programs must satisfy the regulatory requirements of drug licensing authorities. The best way to ensure this is to formulate a sound regulatory strategy early on in the drug development process.

How can we support

 

How we support you

Bringing a pharmaceutical product to market requires expertise to ensure compliance, streamline processes, and achieve successful outcomes. Here’s how we help:

Achieve regulatory compliance

Achieve regulatory compliance

We guide you in meeting all regulatory requirements, ensuring your product aligns with the standards of licensing authorities.

Optimize pre-clinical & clinical testing

Optimize pre-clinical & clinical testing

We ensure your testing is thorough and appropriate, tailored to the specific needs of your product.

Customize testing strategies

Customize testing strategies

We help differentiate and address testing requirements for various product types, including NCEs, line extensions, generics, new indications, and bibliographic applications.
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Why QbD Group?

EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS​ 

Choosing QbD means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.

  • 10+ years of experience: benefit from our team of highly qualified consultants. ​
  • Full life cycle support: full support from pre- to the post-marketing phase.​
  • Global presence​: QbD Group operates globally, at QbD Austria with a special focus on Europe (EU) and China.​
  • Customer satisfaction​: constant evaluation, transparency and clear objectives.​ 
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Have questions about your drug development journey?

Get in touch with our experts to discuss your project needs. Whether you’re at the early stages of drug discovery or preparing for clinical testing, we’re here to help you navigate regulatory requirements, optimize your strategy, and bring your product to market successfully.

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