Asphalion provides reliable support for all types of regulatory procedures and submissions within EU, UK, US and many other regions. We have over 20 years of track record with New Chemical Entities, Biologicals, ATMPs, Orphan Drugs, Generics, OTCs, Herbal Medicines, Homeopathic Medicinal Products, Medical Devices and Food Supplements. We coordinate your submissions, liaise with agencies and solve all potential hurdles, making sure to comply with critical timelines and reducing the time to market. We offer flexible options for support in the submission process, including submission planning, coordination and execution.
Regulatory Procedures Solutions
Schedule a free meeting!
Discuss your case with our experts and receive a valuable feedback
Share
Why Asphalion?
Adaptation to specific regulations and dealing with the Health Authorities can be complex. Whether you are working towards a FDA, EMA or any other regulatory submission, Asphalion can provide its expertise and support for a successful registration process.
Having participated in 18 Centralized Procedures, many DCPs and MRPs involving all European Agencies, more than 30 FDA projects and global roll-outs in emerging markets, our experience keeps growing every day.
We also have extensive experience with the management of translations for regulatory submissions processes, especially for Centralized Procedures (from pre-opinion, until linguistic review and opinion by agencies), in which time and accuracy are critical. We can provide support in managing all required activities and processes where you need expert guidance.
Main benefits
Related Resources
Faster access to treatment
0070 Transparency Policy timeline
Harmonizing Medicinal Product Registration across borders
Highlights video
Highlights video
Highlights video
Highlights video
Highlights video
Highlights video
Webinar recording
Webinar recording
Asphalion End to End support during product lifecycle
Starting 1st of July 2025, the AEMPS mandates the use of Organisation Management System (OMS) for all new Market Authorization Applications and variations for medicinal products registered through National Procedures.
DIA Europe 2025 will focus on sustainability, innovation and collaboration – three key pillars for shaping the future of healthcare. From the environmental impact of pharmaceuticals and of the drug development lifecycle to sustainable partnerships and sustainable healthcare systems, DIA Europe 2025 will be the prime opportunity to discuss how collaboration and innovation can support sustainability in healthcare and each stakeholder’s role in making it happen.
We’re thrilled to announce that the web-based variations eAF is now ready for non-CAPs products across National Procedures (NP), Mutual Recognition Procedures (MRP), and Decentralized Procedures (DCP)! Starting today, eAFs
Services
SDGs
As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
Memberships & PartnershipS
Quality Management System
Innovative SME
SDGs
As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
© Asphalion
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!
