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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
The EMA is gradually resuming clinical data publication activities (beyond COVID-19 medicines).

Transparency Policy 0070

For the time being, the “step 1” of the re-launch has been implemented considering MA applications for new active substances (NAS), that received a CHMP opinion or were withdrawn from September 2023 onwards. “Step 2” is expected to be activated for other applications apart from new actives active substances and Covid-19 treatments during 2024. Clinical data in scope of the policy are defined as clinical reports and individual patient data (IPD). Clinical reports shall mean the clinical overviews and clinical summaries and the clinical study reports (CSR). These documents correspond respectively to modules 2.5, 2.7 and 5.3 of the common technical document (CTD).” oAñadir a continuación: “Clinical reports must be anonymised to prevent patients and professionals who participated in clinical trials from being identified. The approach followed must be described in the Anonymisation report, compiling the risk assessment technique, the anonymisation methods used and their impact on data utility.
Digitalization Highlights
Join the digital wave and revolutionize your Pharmacovigilance strategy with Asphalion!

We offer cutting-edge, validated software solutions to streamline your digital transformation efficiently and effectively.

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.
Webinar Clinical Trials Transition To Ctr Ctis
Upcoming Webinar

Clinical Trials transition to CTR/CTIS

Ready to equip yourself with first-hand information from our experts about CTR/ CTIS? Since we are approaching the second half of the final year of transition, it is crucial for sponsors to plan and submit the transition application #asap to ensure a timely approval and to prevent the potential cessation of trials that do not conform to the new regulation.

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. 

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

Nuria Romero - Asphalion

Núria Romero
Managing Director

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

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