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Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Munich, Amsterdam and London.

Our services


Regulatory and Scientific Strategy during Development

Minimizing time-to-market and maximizing cost efficiency by establishing the right strategy for the product development.


Medical and Scientific Writing

Meticulous and consistent CTD dossier preparation to assure successful registration.


Global Submissions

Assessment of regional requirements based on experience and reliable coordination of local partners for global registration procedures.


eCTD and eSubmissions · ISO IDMP & RIM

Comprehensive eCTD services by using advanced e-tools and efficient Information Management by implementing RIM solutions.


Life-Cycle Outsourcing

Maintenance work support to improve processes and maximize productivity.



Case Management handling and implementing reporting tool. Providing support to set up a Quality system through PV system audits and QPPV services.

Specialists in:
Drugs  –  Biologics  –  ATMPs  –  Medical Devices


Stay tuned! Subscribe to Asphalion Newsletter

Latest news, tips, advice and fresh perspectives on Regulatory Affairs including: deadlines, updates, FDA, EMA, innovative solutions, Brexit, eSubmissions, drug development, guidelines, ODD, strategic consulting, scientific, procedures, roadmaps, etc.

Latest News


September 23, 2021
IN2SIGHT is a project that fosters an unprecedented breakthrough in in-vivo optical imaging that will radically renew the biocompatibility tests of biomaterials. This technology will recast our thinking of biomaterial validation, allowing unprecedented quantitative and longitudinal analyses of the host inflammatory response to the implant.

WEBINAR | Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee Regulatory Perspectives

September 23, 2021
The HESI Cell Therapy – TRAcking, Circulation, & Safety (CT-TRACS) Committee will present a webinar featuring four expert speakers who will share regulatory perspectives from both sides of the Atlantic. One of them will be Marta Rayo Lunar, Regulatory and Scientific Affairs Director at Asphalion.

BIOSPAIN2021 | Roundtable

September 22, 2021
BioSpain, the largest country-based biotech event in Europe will be held in Pamplona and online this year.Our expert, Lidia Cánovas, General Manager, Regulatory Affairs at Asphalion, will be participating in a roundtable during the event together with four other experts.


September 21, 2021
World Alzheimer’s Day was launched in 1994 to mark the 10th anniversary of Alzheimer’s Disease International (ADI) and World Alzheimer’s Month a decade ago, and both have grown significantly since then.