Asphalion
Asphalion, S.L.
Asphalion is a scientific, safety, and regulatory affairs consultancy with offices in Barcelona, Madrid, Munich, and London. They offer comprehensive support for medical device regulations and training for the biotech, pharma, and medtech industries.
Asphalion is an international consultancy firm specializing in Scientific, Safety, and Regulatory Affairs, with a strong presence in Barcelona, Madrid, Munich, and London. Since its founding in 2000, Asphalion has become a reference in the international healthcare sector, offering expert consulting, strategic advice, operational support, and full outsourcing services for all product life cycle stages. They provide comprehensive support for worldwide Medical Device Regulations and training courses tailored for the Biotech, Pharma, and Medtech industries. Their mission is to collaborate with clients to generate ideas and implement solutions that improve health, aiming to be a global reference and a driving force in the evolution of the healthcare sector. With a track record of delivering solutions to over 1,000 companies from more than 50 countries across over 5,000 projects, Asphalion covers non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions, and data management for both medicinal products and medical devices. They also participate in Horizon EU programs and offer services categorized by stage of development, including Preclinical, Clinical development, Registration, and Life-Cycle Management. Asphalion is committed to sustainability, aligning with the UN’s 2030 Agenda and its Sustainable Development Goals.
About
**Who they are**
Asphalion is a scientific, safety, and regulatory affairs consultancy with offices in Barcelona, Madrid, Munich, and London. They offer comprehensive support for medical device regulations and training for the biotech, pharma, and medtech industries.
**Expertise & scope**
* EUDAMED Onboarding & Data Registration Support
* Scientific, safety, and regulatory affairs consultancy
* Support for medical device regulations
* Training for biotech, pharma, and medtech industries
* EU coverage
**Reputation / proof points**
* Offices in Barcelona, Madrid, Munich, and London.
Asphalion is a scientific, safety, and regulatory affairs consultancy with offices in Barcelona, Madrid, Munich, and London. They offer comprehensive support for medical device regulations and training for the biotech, pharma, and medtech industries.
**Expertise & scope**
* EUDAMED Onboarding & Data Registration Support
* Scientific, safety, and regulatory affairs consultancy
* Support for medical device regulations
* Training for biotech, pharma, and medtech industries
* EU coverage
**Reputation / proof points**
* Offices in Barcelona, Madrid, Munich, and London.
Additional information
Asphalion provides a fully managed EUDAMED submission service called AsphaEudaMate. This solution utilizes a Machine-to-Machine (M2M) Massive upload tool integrated with the Data Exchange (DTX) M2M system, enabling automatic, bulk data exchange directly with EUDAMED backend services. The service simplifies submissions by allowing data uploads from a completed spreadsheet, eliminating manual entry into the EUDAMED interface. Asphalion offers end-to-end support, from spreadsheet preparation to XML upload, with fixed-price packages based on UDI volume. They emphasize no recurring fees, with updates provided only when necessary, and the service is designed and operated by MedTech regulatory experts.
Key Highlights
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Offers AsphaEudaMate, a Machine-to-Machine (M2M) Massive upload tool for EUDAMED submissions.
Source
“AsphaEudaMate is a Machine-to-Machine (M2M) Massive upload tool integrated into the Data Exchange (DTX) M2M system”
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Provides end-to-end support for EUDAMED submissions, from spreadsheet to XML upload.
Source
“End-to-end support: from spreadsheet to XML upload”
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Features fixed-price packages tailored to UDI volume with no recurring fees.
Source
“Fixed-price packages tailored to your UDI volume No recurring fees — updates only when needed”
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Designed and operated by MedTech regulatory experts.
Source
“Designed and operated by MedTech regulatory experts”
Certifications & Trust Signals
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Consultancy with offices in Barcelona, Madrid, Munich, and London.
Source
“Asphalion is a scientific, safety, and regulatory affairs consultancy with offices in Barcelona, Madrid, Munich, and London.”
Buyer Snapshot
Best for
- Companies seeking streamlined EUDAMED submissions
- Organizations needing bulk UDI uploads
- Biotech, pharma, and medtech industries
How engagement typically works
- Fully managed service
- Consulting and strategic advice
- Operational support
- Full outsourcing services
Typical deliverables
- EUDAMED submission support
- AsphaEudaMate tool for M2M uploads
- Spreadsheet to XML data conversion
- UDI bulk upload facilitation
Good to know
- Best when requiring efficient, non-manual data submission to EUDAMED.
Pricing
Model:
Per project
HQ:
Barcelona, ES
Languages:
English, Spanish, French, German
Timezones:
CET, GMT
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Jurisdictions:
EU
Countries:
Spain, France, Germany, Italy
Industries:
Medical Devices, IVD
Pricing model:
Per project
Modules Supported:
Actor/SRN
Submission Approach:
Portal
Portfolio Fit:
100+
Onboarding Speed:
6+ weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping, Labeling mapping, Access point onboarding
eudamed_m2m
Jurisdictions:
EU
Countries:
DE, FR, GB
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Additional eudamed_onboarding_support Details
Modules Supported
UDI/Devices
Submission Approach
M2M integration, bulk submissions
Data Mapping Capability
Mapping from spreadsheets to EUDAMED format.
Validation Playbook
Optional discounted data entry and validation services are available.
