International Recognition Procedure (IRP)
A must-watch for anyone involved in regulatory affairs or lifecycle management.
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
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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
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Webinar recording
At Asphalion, we’re excited to be part of key events, conferences, and summits throughout 2026—great opportunities to connect, exchange insights, and collaborate with leaders across healthcare and medical devices.
DIA Europe 2026 will take place in Rotterdam from 24–26 March 2026. As Europe’s largest neutral conference in the life sciences sector, it will gather 1,500 professionals from over 50 countries for three days of exchange and collaboration. The programme features 10 dynamic tracks covering key areas such as Clinical Trials Innovation, AI & Real-World Evidence, Innovative Therapies, Medical Devices, and Pharmacovigilance, alongside 80+ sessions and contributions from 300+ experts, regulatory authorities, HTA bodies, payers, and patient organizations—offering a key platform to drive innovation and informed decision-making in healthcare.
Meet Our Experts at the 24th RA Conference by Medicines for Europe next week!
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!
