Drug Development
From discovery to market
Drug development entails drug discovery, pre-clinical and clinical testing. New chemical entities need to show minimum standards of safety, toxicity, pharmacokinetics and metabolism before they can be placed on the market.
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 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 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
We guide you in meeting all regulatory requirements, ensuring your product aligns with the standards of licensing authorities.
Optimize pre-clinical & clinical testing
We ensure your testing is thorough and appropriate, tailored to the specific needs of your product.
Customize testing strategies
We help differentiate and address testing requirements for various product types, including NCEs, line extensions, generics, new indications, and bibliographic applications.
Why QbD Group
Your trusted partner
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.
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, with QbD Austria having a special focus on Europe (EU) and China.
Customer satisfaction: constant evaluation, transparency and clear objectives.
Let's talk Regulatory Affairs
From regulatory strategy to product approval, our experts are ready to guide you through every step.