last update 2021-09-18

Product Compliance

means on the floor of dozens of different national rules and laws - each step forward in any country with newly developed health products, medical devices, drugs and even supplements and dietary food looks like playing a puzzle which is getting piece by piece more complete, transparent and valuable. But the truth is, it’s not a puzzle which is ever completed.  
All of the rules and laws for registrating and marketing for drugs, medical devices, etc. are always considered as temporary - they are always and everywhere in a process of modernizing in a way as the law makers like to see it - which means it’s never really predictable.

The continuing process of renewing country specific rules and laws influence the opportunities to put and hold health products successfully on the market all the time and everywhere.  Always one step ahead of this process is the best solution.

 

Different

In every part of our daily work we are concentrated only on projects for which we are able to guarantee short and long term success.  In this case, it means on one hand we do not offer the registration process of prescription drugs.  But on the other hand we are specialized to do the following:

 

  • We create and guarantee on a country specific basis the compliance for standardized OTC, medical devices, health products, supplements and cosmetics.We are not only familiar with the rules and laws - we are especially creative in the reading and handling of those regulations and we have strong connections with the ruling institutions.
  • We maintain our contacts in  all of the involved health departments and institutions in the countries where we have offered our services for many years. 
  • We are continually involved in country specific discussions regarding the implementation of new regulations, laws and rules.
  • We not only know the interests of all the involved institutions and companies from politicians to insurers - we also know their visions.

 

In Germany, United States we register OTC, medical products, supplements and cosmetics. We create claims and guaranty compliance for the text and visualizing of packages, package inserts, etc.: plus we know in all of these countries the opportunities and hurdles of reimbursement. In Belgium, France, Ireland, Italy, The Netherlands, Portugal, Switzerland, Cyprus, Denmark, Finland and Baltic States, Greece, Hungary, Iceland, Spain, Sweden, Turkey and United Kingdom we recomment to work with our Agora Partners. www.agora-consulting.org


You profit from the difference.