Project Orbis Partner
Faster access to treatment
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
Related Resources
Faster access to treatment
0070 Transparency Policy timeline
Harmonizing Medicinal Product Registration across borders
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Asphalion End to End support during product lifecycle
We have summarized all DCP steps in this flow chart for you to download and keep always at hand.
The European Commission has officially adopted revisions to the Variations Regulation, set to take effect in January 2025. This update brings important changes to the regulatory landscape, and the accompanying
Many key takeaways and highlights from the DIA RAPs Regulatory Policy Forum!! Capitalizing on the success of their joint collaboration this past January for 2024 Combination Products in the EU, DIA and the Regulatory Affairs Professionals Society (RAPS) are coming together once again to produce the 2024 Regulatory Policy Forum.
Designed specifically for regulatory policy leaders, senior decision makers, and regulators across the pharmaceutical community, this summit will explore the new EU pharmaceutical legislation and how it will shape the future of the pharmaceutical arena—including research, development and manufacturing—in Europe for decades to come.
The first-ever conference on medicinal products promotion in Catalonia brought together industry leaders to discuss the latest updates, challenges, and opportunities in ensuring ethical and compliant pharmaceutical marketing practices. Key
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As a company committed to sustainability, we follow the UN’s 2030 Agenda and its Sustainable Development Goals.
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