In the highly regulated and complex environment of the Spanish National Health System, it is critical to have expert advice on regulatory and technical issues related to medicines, and more precisely with Orphan Drugs. This insight about the administrative procedures are a must in order to successfully market any drug approved by the EMA (European Medicines Agency) in Spain.
Price & Reimbursement Request for any Drug in the National Health System:
Relationships & Processes with the Spanish Medicine Agency (AEMPS)
Relationships & Processes with the MoH
Relationships & Processes with the different Region Health Departments
Procedures for using Drugs under Special Situations (Early Access Procedure and Foreign Drug)
Relationships with Patient Organizations
Relationships with Scientific Associations
Prior to begin the marketing of any Orphan Drug, it is essential to understand who the right audience may be by conducting an in depth market study. Then, once the target is identified, a meticulous contact strategy has to be developed in order to influence this group.
Identify and Contact with the corresponding KOL’s for each medical specialty related with the disease treated with the Drug
Identify the Diagnostic Centres
Identify the Expert Committees members
Marketing & Selling
Our mission is to develop the right strategies and actions with the goal of getting the drug properly prescribed to each patient diagnosed. And then, that the patient receives his/her treatment on time following the clinical needs regulated by the specialists.
Design of frequency and intensity of promotion activities
Assistance in contracts for premarketing services, marketing, and any other service of interest to a pharmaceutical company.
Reports on promotion, advertising, data protection, communication through websites.Support and direction in all types of procedures with any Health Authority. Defense, including civil and administrative litigation, either before competitors or before the Administration.
Supplier of programs and procedures of Criminal Enforcement (Compliance)
Mandatory for companies since July 2015
Identification of research projects
Given our background and existing links we can offer meaningful support in the selection of people more adequate to start, develop and/or continue business objectives in Spain adapted to the specific profile, mission and vision of the interested company