last update 2021-06-25

Product Compliance

in the health systems around the world needs much more than global knowledge.  

A harmonization of all of the rules and laws for the registration of drugs, medical devices, health products, supplements or even cosmetics is on a global level neither insight, nor in the relatively small Europe realized.  From country to country the rules for the registration are more or less different. The rules for the identification, the text for package inserts, claims, etc. needs not only more than local knowledge - to be successful in the process of registration local action is a big advantage.  

The harmonization for a product portfolio with the goal to have the same text, claims, etc. in Europe and the United States is rarely a recommended goal.  Instead of that, in most cases it is more successful to make a difference which includes the specifications of the local market.

Different

Not only for us, but especially for us, it’s true:  Even in areas where we have proven our knowledge, competence and experience and won the trust of our customers, there are gaps and niches where we think other consultants are better than we are.  

Although we have regular requests to do drug registration, we are not active in this area.  But we have, in Germany as well as in the United States, partners which we trust and where we are sure our customers can trust them too.  

The same is true for activities in the areas of the registration of medical devices, medical products, standardized OTC, supplements and cosmetics in countries of the EU where we do not have personal connections to the involved health departments.   

To make sure the registration process of a health product in a foreign country is not only done in a lawful way but also in a creative way based on the flexible handling of the laws and rules, the cooperation with a local consultant is necessary.

This is the reason why we are engaged in a network - http://www.agora-consulting.org/ - of highly specialized consultants in Europe which guarantees the perfect service in the specific country.

We provide our service in Germany and the United States.  We recommend to work with our Agora Partners in Belgium, France, Ireland, Italy, The Netherlands, Portugal, Switzerland, Cyprus, Denmark, Finland and Baltic States, Greece, Hungary, Iceland, Spain, Sweden, Turkey and United Kingdom. www.agora-consulting.org


You profit from the difference.