last update 2021-09-18

National Regulations

are often thought of as a hurdle for successful marketing of drugs, medical devices and health products.

This is especially true in cases when different countries have different or even contrary rules and laws regarding the health market.  In these cases, compliance is not only a question of law; it is a country specific puzzle.  

National regulations are not only made to protect patients and consumers, they also represent the interest of politicians and insurers.  Whoever misses the chance to think, plan and act in these categories gives up the opportunity to create products and strategies which are compatible on a long lasting range. Mistakes in this area can make successful strategies fail immediately.

Different

Out of an international view, it’s even true for Europe:  the different interests of governments, health departments and insurers create; even within Europe, such different conditions that nobody can talk about a mutual European health market.
 
The market in the United States gives on the bottom of more central regulations more and better opportunities in the area of registration and declaration of health products, medical devices and drugs.  But the marketing of the products is ruled by conditions, laws and regulations from and for the health insurers. These rules are not even from insiders always considered as transparent.

Based on these facts it’s not only the compliance but also the creative reading and handling of laws, regulations, etc. which decide about a permit and the ability to put health products successful into different markets in Europe and the United States.  First, but not least, the most creative ideas in this area has to be checked and cleared with the involved national institutions.

The expectations which are created with the best ideas are theory as long as you see laws, regulations, etc. as an administrative fact.  For each country you need to have a personal contact with the regulatory commission to make your case a successful story. That’s the reason why we are concentrated on areas where we not only have the necessary knowledge and experience but also the necessary personal contacts.

In Germany, Netherlands, Spain, France, Great Britain, Ireland, Portugal, Greece and the United States we register OTC, medical devices, 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.

You profit from the difference.