Regulatory, Scientific & Safety Consulting in Life Sciences

Expert consulting, strategic advice, operational support and full outsourcing services for all product life cycle stages

Regulatory, Scientific & Safety Consulting in Life Sciences

Expert consulting, strategic advice, operational support
and full outsourcing services for all product life cycle stages

ASPHALION is an international Scientific, Safety and Regulatory Affairs consultancy company with offices in Barcelona, Madrid, Pamplona, Munich and London.

Initial Maa Timeline
EMA gradually resuming clinical data publication activities

Transparency Policy 0070

EMA has resumed the publication of clinical data beyond COVID-19 medicines. Since 2025, this applies to all new marketing authorisation applications (MAAs), including positive and negative CHMP opinions, withdrawals, line extensions, and major clinical variations.

The scope includes clinical reports and individual patient data, which must be anonymised following strict methodological criteria.

Click the image to download the full timeline in PDF.
Digitalization Highlights
Join the digital Pharmacovigilance wave!

Cutting-edge, validated software solutions

Experience innovation, reliability, and excellence with the most-innovative technology on the market: AI validated tools led by the highest quality standards to centralize your safety activities in one place.
Asphalion Knowledge Centre
New Service

Asphalion Knowledge Centre

Elevate your expertise in Biotech, Pharma, and Medtech with Asphalion Knowledge Centre. Premier training by industry specialists for EU and US regulations.

Its strong track record has made ASPHALION a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards

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ASPHALION’s experts have delivered solutions to over 1,000 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 5,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices. 

Nuria Romero - Asphalion

“We excel in what we do and we strongly believe that Knowledge comes from Experience, and here lies Asphalion’s most valuable strength.”

Núria Romero | CEO

Services by Product

Asphalion Global reach

Our international essence has taken us to have clients in more than 50 countries.

Our clients come from  Germany Switzerland USA France United Kingdom Italy Spain India China Korea Denmark Brazil Portugal  Japan Belgium Israel Sweden  Mexico Canada GCC Australia Austria Argentina Finland Czech Republic Greece Saudi Arabia Turkey Ireland Poland Bulgaria Luxembourg Moldova Ukraine Egypt Cyprus Croatia Lebanon Malta Romania Thailand Lithuania Iceland Malaysia Hungary Latvia

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

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Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

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