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.
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 we support you
- We help you to meet the regulatory requirements
- Ensure adequate pre-clinical and clinical testing for the right product
- Differentiate between testing requirements, NCEs, line extensions, generics, new indications, bibliographic applications
Why QbD Group?
Benefit from our team of highly qualified consultants. ​
Full support from pre- to the post-marketing phase.​
QbD operates globally, at QbD Austria with a special focus on Europe (EU) and China.​
Constant evaluation, transparency and clear objectives.​
Contact us
Contact us for more information or to request a free, no-obligation proposal.
