Produktliste Vertriebspartner Kontakt Aktuelles / News AGB + Käuferschutz Über AlphaScience About AlphaScience B2B Projekte Impressum Sitemap

Marketing Service

Asking for help is a sign of strength

The IvD markets in the various European countries are fragmented between public and private sectors, by medical traditions and not least by reimbursement policies.
AlphaScience provides you with solutions for both regulatory and commercial aspects of bringing your products to the German and European markets.

IVD & CE-mark

With the application of the IVD Directive in December 2003, the European Union (EU) has mandated that all IVD devices for use in the human clinical setting must be registered and have the CE-mark affixed. Each EU country and certain affiliated countries, such as Switzerland, have legislated for the languages that are acceptable for the IVD product labelling in that country.
AlphaScience can organize the translation of product labelling into appropriate languages and we can act as interface for all legal and technical issues regarding product registration and performance in Germany and Europe.
AlphaScience can act as your Authorized Representative in the European Community for the Europe IVD:

  • Business Development and coaching your company for local Biotech, Health Care and Life Science markets.
  • Marketing and PR-Management, adapted to the local markets.
  • Recruiting of employees.
  • Build up a distribution network for short-term start up.
  • Manage your existing European distributor network together with and under the guidelines laid out by your Management.
  • Build up local Sales & Service Operations coach and control those operations.
  • Search and identify local cooperation partners in your marketplace.
  • Search and support strategic mergers and acquisitions.
  • Taking care of local requirements for Regulatory Affairs .
  • We can interact with the relevant Notified Body (Annex II products).

About AlphaScience