Asphalion is an international Scientific and Regulatory Affairs Consultancy serving Pharma, Biotech, and Medtech companies. They provide comprehensive services throughout the entire lifecycle of a medicinal product or medical device, from early development through to post-marketing. Key areas of expertise include regulatory strategy, submissions (EMA, FDA, etc.), pharmacovigilance, GxP compliance, medical writing, and data management solutions like IDMP.
Serves as the central hub for Asphalion's global operations, strategic decision-making, core service delivery, and client management.
Modern office facilities located in a prominent business district of Barcelona, designed to foster collaboration and innovation.
Characterized by a strong emphasis on scientific excellence, regulatory expertise, client-centricity, teamwork, and continuous learning in a dynamic international environment.
Barcelona is a significant European hub for the pharmaceutical and biotech industries, providing access to talent, research institutions, and a vibrant life sciences ecosystem.
Asphalion supports clients globally with their scientific and regulatory needs. This includes managing submissions to major health authorities such as the EMA (Europe), FDA (USA), MHRA (UK), Health Canada, Swissmedic, and others across Asia-Pacific and Latin America. Their services encompass global regulatory strategy, pharmacovigilance, quality management systems (GxP), and data solutions applicable across multiple jurisdictions.
Av. de la Diagonal, 601, 8ª planta
Barcelona
Catalonia
Spain
Address: Landsberger Str. 302, 80687 München, Germany
To cater specifically to the significant German pharmaceutical and medical device market, offering tailored expertise for national regulatory procedures.
Address: Fred. Roeskestraat 115, 1076 EE Amsterdam, Netherlands
Strategic location for EMA engagement, facilitating EU-centralized procedures and offering a key operational base within the EU.
Address: 85 Great Portland Street, First Floor, London, W1W 7LT, United Kingdom
To provide expert navigation of the UK's distinct regulatory landscape following Brexit and support clients targeting the UK market.
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As of April 2025, ASPHALION' leadership includes:
ASPHALION has been backed by several prominent investors over the years, including:
Asphalion has maintained a stable core executive team. No major C-suite level hires or departures have been publicly announced in the past 12 months, indicating continuity in leadership.
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Asphalion typically uses a standard professional email format, most commonly combining the first initial and last name of the employee.
[first_initial][last]@asphalion.com
Format
nromero@asphalion.com
Example
85%
Success rate
Asphalion Website • March 12, 2024
Asphalion announced its participation and presentations at the DIA Europe 2024 conference in Brussels, showcasing their expertise in regulatory affairs and clinical development....more
Asphalion Website • February 20, 2024
Asphalion published insights into the complexities of Post-Market Surveillance (PMS) and vigilance requirements under the new EU Medical Device Regulation (MDR)....more
Asphalion Website • October 23, 2023
Asphalion shared its involvement and contributions at the TOPRA Annual Symposium 2023 in Lisbon, engaging with regulatory professionals and discussing industry trends....more
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