Our team of Regulatory affairs experts make our service offerings stronger.
Carrying out the readability user test
It is carried out in English, German and each of the other official EU languages in accordance with SLESS and WISEMAN. For this purpose,
Support for regulatory dossier submissions around the world in both eCTD and non-eCTD formats:
Our consulted laboratories are GMP certified and they have a manufacturer authorization for Quality Control purposes. We can offer the following services:
According to EU regulations, medicinal products imported into the European Economic Area (EEA) from third countries have to be certified by a Qualified Person (QP) to be released into the market. Companies based in countries with Mutual Recognition Agreements have no obligation to retest the batches, although batch certification is always required. We offer:
Our expert can help you in various segments including following.