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 specialized consultancy focused on navigating the complexities of the EU market for medical devices, cosmetics, food supplements, and pharmaceuticals. They offer comprehensive regulatory and logistical support to ensure compliance and market access.
**Expertise & scope**
* Regulatory strategy and implementation for EU market entry.
* Logistical support for product compliance.
* Expertise across medical devices, cosmetics, food supplements, and pharmaceuticals.
* Support for EUDAMED Onboarding & Data Registration.
**Reputation / proof points**
* Based in Spain, serving clients targeting the EU market.
ASC Services is a specialized consultancy focused on navigating the complexities of the EU market for medical devices, cosmetics, food supplements, and pharmaceuticals. They offer comprehensive regulatory and logistical support to ensure compliance and market access.
**Expertise & scope**
* Regulatory strategy and implementation for EU market entry.
* Logistical support for product compliance.
* Expertise across medical devices, cosmetics, food supplements, and pharmaceuticals.
* Support for EUDAMED Onboarding & Data Registration.
**Reputation / proof points**
* Based in Spain, serving clients targeting the EU market.
Additional information
ASC Services focuses on navigating the complexities of the EU market for a range of regulated products. Their support extends beyond initial registration to encompass ongoing logistical requirements, ensuring sustained compliance for medical devices, cosmetics, food supplements, and pharmaceuticals. Buyers engaging ASC Services can expect a partner adept at managing the specific regulatory landscapes of these diverse product sectors within the European Union.
Key Highlights
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Offers 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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Specializes in EUDAMED Onboarding & Data Registration.
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 medical devices, cosmetics, food supplements, or pharmaceuticals.
- Businesses requiring regulatory and logistical support.
How engagement typically works
- Consultative approach to regulatory challenges.
- Partnership for ongoing compliance.
Typical deliverables
- EU market access strategy.
- Regulatory compliance documentation.
- Logistical compliance planning.
Good to know
- Best when requiring specialized knowledge of EU regulations for specific product categories.
HQ:
Sevilla, ES
Languages:
Spanish
Timezones:
UTC+1
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Modules Supported:
Actor/SRN, UDI/Devices
Submission Approach:
Portal, M2M Integration
Portfolio Fit:
1-5
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
