Regulatory

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

Pre-Marketing

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.

Market Research

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.

Marketing Plans

Launching Plans

Awareness Campaigns

Design of frequency and intensity 
of promotion activities

Research Support

Identification of research projects

Feasibility analysis

Fundraising

Staff Selection

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

Contact
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