Drug evaluation is the process of assessing and analyzing drugs by qualified experts and organizations in order to determine their safety, quality and efficacy (German: Wirksamkeit). This process is an integral part of the marketing authorization and monitoring of drugs before they can be approved for sale and use by patients.

Expertise in drugs covers the following main aspects:

• Clinical trials: These are studies carried out on humans to assess the safety and efficacy of a drug. These studies usually comprise several phases, ranging from tests on a small group of volunteers to large-scale studies with a large number of patients.
• Data analysis: The results of clinical trials (translation into German: klinische Studien) are analyzed and tested for statistical significance.
• Documentation: Drug manufacturers provide detailed documentation on the chemical composition, manufacturing methods, packaging and storage.
• Pharmacological analysis: Experts investigate the pharmacological properties of drugs — mechanisms of action, possible interactions and side effects (German translation: Nebenwirkungen).
• Safety: An assessment of the potential risks and side effects associated with the use of the drug.
• Quality: Verification that the drug meets quality standards, including composition, purity and stability.
• Compliance with regulations: Ensuring that a drug fulfills the requirements of regulatory and health authorities.
• Packaging and labeling: Checking the accuracy of the information on the packaging, labeling and in the package leaflet.

The evaluation of drugs ensures that the drugs available on the market are safe to use and have proven efficacy. Regulatory authorities and independent experts play a key role in this process, which protects the health and safety of patients.

You can book experienced pharmaceutical interpreters and GMP translators for your GMP inspection in Russian or English with us. You can concentrate on your content and the inspectors; we will take care of the verbal communication. Simply contact us for a quote!

We also offer the following services: Consultancy in the run-up to a GMP inspection, representation of international pharmaceutical companies and distribution of their products in Germany. If you are looking for a new position in the pharmaceutical industry, we are happy to support you with our contacts at a large number of pharmaceutical companies all over the world.