Drug development is a complex process on the way to a new or improved drug (British English: medicinal product), which includes the search for new active pharmaceutical ingredients, the subsequent investigation of their properties, preclinical research, the development of technologies for the manufacture of pharmaceutical substances and the development of formulations and technologies for the manufacture of drugs.

Drug development involves a series of phases, all of which serve to ensure the quality, efficacy and safety of the drug.

The most important phases of drug development include:

• Research and development (translation into German: Forschung und Entwicklung): In this phase, research is carried out to identify potential targets (proteins, genes, molecules) that could be related to the disease. The researchers then develop candidate molecules that can interact with these targets.
• Preclinical research: In this phase, the candidate molecules are subjected to extensive in vitro and animal testing to assess their toxicity, pharmacokinetics (German: Pharmakokinetik), pharmacodynamics and other parameters. In this phase, the most promising candidates are selected for further testing.
• Clinical trials: This phase comprises three phases of clinical trials on humans. Phase I: evaluation of safety and tolerability in a small group of volunteers. Phase II: evaluation of efficacy and determination of the dose in a larger group of patients. Phase III: confirmation of efficacy and safety in a larger group of patients.
• Marketing authorization: Once the clinical trials have been successfully completed, the pharmaceutical company submits an application for marketing authorization of the drug to the regulatory authority. If the results of the studies fulfill the efficacy (German translation: Wirksamkeit) and safety requirements, the drug can be authorized for use.
• Large-scale manufacture: After the drug is granted marketing authorization, manufacturing the drug for distribution starts. Here, validation of manufacturing methods and guaranteed product stability and quality are required.
• Monitoring of side effects: The side effects and reactions of patients to the drug are monitored after the market launch. This is called pharmacovigilance.
• Post-marketing studies: In some cases, additional studies may be conducted after a drug has been placed on the market to further evaluate its efficacy and safety.

The process of drug development is highly regulated and aims to ensure access to safe and effective drugs to treat a wide range of diseases.

As experienced pharmaceutical interpreters and GMP translators, we are happy to accompany you during your GMP inspection by foreign regulatory authorities and ensure flawless communication between the pharmaceutical company and the team of inspectors. Simply send us an email or contact us by telephone.

Moreover, we also offer further services, such as consultancy services in the run-up to a GMP inspection, representation of international pharmaceutical companies and distribution of their products in Germany. Thanks to our long-standing cooperation with a large number of pharmaceutical companies around the world, we can also support you if you are looking for a new position in the pharmaceutical industry.