We are introducing ourselves as a group of pharmacists, chemists and biologists with experience in pharmaceutical industry and Regulatory Affairs.
Sine 1985, European Community is striving to create a common market for medicinal product registration by foster the same legislation throughout the all Member State and EEA countries.
Therefore, we created this site and our commitment is to bring a clear view about the directives, the decisions, the regulations and the guides, which are referring to medicinal products. We will analyze those texts and will explain using common words the most important articles.
Our statement is to be an useful toll for professionals in the area which could view this site as an preview of important information about medicinal products; we address also to pharmaceutical business sector that will find in our team a good collaborator and a trustful partner.
For cosmetics and medical devices, European legislation is already endorses so we have a succinct presentation of these. Food supplements regulations differ from a country to another so we offer presentation of Romanian legislation and also, advices for legislation in other countries.
Collecting, evaluation and reporting of adverse drug reactions and adverse events is an important activity addressed both the medicinal product and medical devices. Marketing Authorization Holders and Companies who own the registration certificate for medical devices has the responsibility to follow the safety in administration of their products, granted by an advisable pharmacovigilance system. We create such a system suitable for your Company, in respect of national/European guides and legislation. You can delegate to us all pharmacovigilance activities and we take over your responsibility.
News category in our site comprise in an overview of the important activities, news, press release, conferences program, regarding to European and worldwide public health.
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