How can American and other non European biopharmaceutical companies and their products gain a foothold in Europe? That is the question German pharma service provider Diapharm will be answering at this year’s BIO International Convention in San Diego, USA. At the German pavilion (booth 707) Diapharm General Manager Dr. Guido Middeler will be presenting the “legal representative plus” model for the management and coordination of all formal tasks and matters of substance relating to marketing authorizations for medicinal products and clinical trial applications in Europe.

Biopharmaceutical companies wishing to conduct a medicinal product study in Europe have to clear a number of hurdles, but ultimately stand to gain marketing authorization for an enormous market of 493 million people. Diapharm is offering the services required in a package called “legal representative plus”. For example, the pharma service provider produces Investigational Medicinal Product Dossiers (IMPD) according to EU specifications, coordinates clinical studies and takes care of laboratory analysis and batch release for imports of, say, genetically engineered drugs. The company also performs the formal function of acting as “legal representative” for the sponsor, since studies can be performed in Europe only if the sponsor has its own registered office or a legal entity of this kind.

Diapharm supports companies in the medicinal and health products industry in all regulatory, medical and pharmaceutical matters to do with medicinal products, medical devices, food supplements, biocides, and cosmetics. More than 80 people work for the German-based company.
The BIO International Convention is being held at the San Diego Convention Center (California, USA) on June 17 to 20, 2008.