Company intelligence
ASPHALION
Scientific and Regulatory Affairs consultancy with offices in Barcelona, Madrid, Munich and London.
About ASPHALION
Asphalion is an international Scientific, Regulatory and Safety Consulting In Life Sciences, with offices in Barcelona, Madrid, Munich and London. We collaborate with Pharma and Biotech companies facilitating Drug Development and Regulatory Affairs projects for Drugs, Biologics, Biosimilars, ATMPs and Medical Devices. Our involvement ranges from early development, throughout registration, until marketing and post-commercialization phases. Since the company foundation in 2000, we have consistently grown and now have a team of over 100 employees with backgrounds in all areas of life sciences. Our consultants are experts in their fields and are in direct contact with European agencies for the im-plementation of new regulatory standards. We provide global services and work for hundreds of clients from around the world. Through collaborations with partners in all other continents, we can accelerate your worldwide scientific and regulatory activities by using local expertise. Medicines for Europe (MFE) members. Awarded sustainable company by EcoVadis.
Verified activity
Signals from ASPHALION
10 published signals
Research & Knowledge
ASPHALION completed Week 10 of the Summer Quiz 2026 with 73% answered correctly on Day 45 regarding software modifications requiring a new UDI-DI.
Reported by ASPHALION
Research & Knowledge
ASPHALION completed Week 10 of the Summer Quiz 2026 with 68% answered correctly on Day 44 regarding the new revision of ICH M4Q.
Reported by ASPHALION
Research & Knowledge
ASPHALION completed Week 10 of the Summer Quiz 2026 with 67% answered correctly on Day 47 regarding the EMA submitting reports annually on new variation classifications.
Reported by ASPHALION
Research & Knowledge
ASPHALION completed Week 10 of the Summer Quiz 2026 with 65% answered correctly on Day 48 regarding the dossier impact.
Reported by ASPHALION
Research & Knowledge
ASPHALION completed Week 10 of the Summer Quiz 2026 with 17% answered correctly on Day 46 regarding the FDA designation Breakthrough Therapy.
Reported by ASPHALION
Customers & Market
ASPHALION provides Medical & Scientific Writing and Regulatory Affairs support to pharmaceutical and biotechnology companies throughout the development of Orphan Drugs.
Reported by ASPHALION
Presence & Recognition
ASPHALION is hosting a webinar titled PMS Progress Overview on October 1 at 3:00-3:30 p.m. CET on a virtual platform.
Reported by ASPHALION
Presence & Recognition
ASPHALION hosted DMD patient groups as part of its commitment to patient and public engagement.
Reported by ASPHALION
Partnerships
ASPHALION has been a regulatory partner for several projects developing new treatments for Duchenne muscular dystrophy.
Reported by ASPHALION
Presence & Recognition
ASPHALION is hosting a webinar on Key Quality (CMC) challenges for Advanced Therapy Medicinal Products (ATMPs) on 17 September at 3:00–3:30 p.m. CEST.
Reported by ASPHALION