ASC Services
ASC Services offers comprehensive regulatory and logistical support for medical devices, cosmetics, food supplements, and pharmaceuticals in the EU market.
ASC Services provides integrated advice and management for medical device licensing, design, certification, and market entry, ensuring compliance with EU Regulations 2017/745 and 2017/746, along with quality standards implementation. They offer full support for manufacturers and importers of cosmetics, including CPNP and CPSR processing, and have extensive experience in managing sanitary registrations for food products (RGSEAA), adapting labeling, and market communication within the EU. Their expertise extends to managing technical information for medicines, active ingredients, and manufacturing/import/distribution facilities. ASC Services also conducts quality control, biocompatibility, and toxicological testing for medical devices, cosmetics, medicines, and food products. They leverage experienced partners for comprehensive management of transport, import, customs clearance, and logistics for these product categories. Additionally, ASC Services offers a validated ERP system for integrated quality management of medical devices, cosmetics, and medicines, alongside custom IT solution development. They provide tailored training for companies in the health sector and specialized courses on medical devices and cosmetics.
About
**Who they are**
ASC Services is a provider specializing in regulatory and logistical support for various product categories within the EU market. They focus on ensuring compliance and facilitating market access for their clients.
**Expertise & scope**
* Comprehensive regulatory support for medical devices, cosmetics, food supplements, and pharmaceuticals.
* Logistical assistance for navigating the EU market.
* Support for EUDAMED Onboarding & Data Registration.
**Reputation / proof points**
ASC Services is a provider specializing in regulatory and logistical support for various product categories within the EU market. They focus on ensuring compliance and facilitating market access for their clients.
**Expertise & scope**
* Comprehensive regulatory support for medical devices, cosmetics, food supplements, and pharmaceuticals.
* Logistical assistance for navigating the EU market.
* Support for EUDAMED Onboarding & Data Registration.
**Reputation / proof points**
Additional information
ASC Services assists businesses in meeting EU regulatory requirements for a range of products including medical devices, cosmetics, food supplements, and pharmaceuticals. Their services are designed to streamline the process of market entry and ongoing compliance within the European Union. Clients can expect support in navigating complex registration procedures and logistical challenges.
Key Highlights
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Provides regulatory and logistical support for medical devices, cosmetics, food supplements, and pharmaceuticals.
Source
“ASC Services offers comprehensive regulatory and logistical support for medical devices, cosmetics, food supplements, and pharmaceuticals in the EU market.”
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Based in Spain, offering support for the EU market.
Source
“ASC Services offers comprehensive regulatory and logistical support for medical devices, cosmetics, food supplements, and pharmaceuticals in the EU market.”
Certifications & Trust Signals
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Based in Spain.
Source
“ASC Services offers comprehensive regulatory and logistical support for medical devices, cosmetics, food supplements, and pharmaceuticals in the EU market.”
Buyer Snapshot
Best for
- Companies seeking EU market entry for regulated products.
- Businesses needing assistance with EUDAMED registration.
How engagement typically works
- Provider offers regulatory and logistical support.
- Focus on compliance and market access.
Typical deliverables
- EUDAMED onboarding and data registration.
- Regulatory compliance documentation.
- Logistical support for EU market operations.
Good to know
- Best when clients require support for medical devices, cosmetics, food supplements, or pharmaceuticals in the EU.
HQ:
Sevilla, ES
Languages:
Spanish
Timezones:
UTC+1
Claim status:
Listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Modules Supported:
Actor/SRN, UDI/Devices
Submission Approach:
Portal, Bulk Submissions, M2M Integration
Portfolio Fit:
26-100
Onboarding Speed:
2-6 weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping, Labeling mapping
Additional eudamed_onboarding_support Details
Modules Supported
Actor/SRN, UDI/Devices
Submission Approach
Portal operations
⚡ Instant booking available
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