The drug development process requires a diversity of strategies addressed towards enhancing a product’s value for the society. Therefore, understanding specific local needs, processes, standards, laws and crucial contacts maximizes future market possibilities in each context.
Furthermore, the Spanish market represents one of the biggest potentialities due to the volume of its health expenditure, which positions it as an interesting and essential strategic region. To this purpose, we can offer a deep understanding based on our experience about the local Spanish regulatory environment, as well as its agents, involved authorities, communications flow and calendars, etc., all of them key to ensure a successful and efficient registration, commercialization, and post-marketing product life.
The drug development process requires a diversity of strategies addressed towards enhancing a product’s value for the society. Therefore, understanding specific local needs, processes, standards, laws and crucial contacts maximizes future market possibilities in each context.
Furthermore, the Spanish market represents one of the biggest potentialities due to the volume of its health expenditure, which positions it as an interesting and essential strategic region. To this purpose, we can offer a deep understanding based on our experience about the local Spanish regulatory environment, as well as its agents, involved authorities, communications flow and calendars, etc., all of them key to ensure a successful and efficient registration, commercialization, and post-marketing product life.
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Why Asphalion?
Asphalion is the largest regulatory affairs consultancy firm in Spain. This has been achieved in parallel to our experts having developed an excellent personal relationship with the national regulatory entity, the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), as well as with the Ministry of Health and its derivative organ bodies, backed up by more than 20 years of presence. Together with our profound understanding of the local legislation and knowledge of agencies’ preferences and internal processes, Asphalion is your best choice as local regulatory partner in Spain. This is complemented by:
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