Your Consultant on EU Regulations
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Our Solution:
We support your product launch to the EU Market through documentation review, product registration and legal representation. SERVICES
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Our Quality:
Our support is managed by our Quality System which is certified ISO 9001 & 13485.
TESTIMONIALS
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Our Team:
Our team is comprised of Lawyers, Chemists, Pharmacists and Regulatory Experts with several decades of experience in EU affairs. ABOUT US
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Meet us
Our Services
Representing non-EU based manufacturers in a successful EU Market entry and safeguarding their future across the entire community.
Learn MoreEnsuring compliance and registering products to be made available on the EU Market.
Learn MoreFor your products to legally enter the EU Market and continue to circulate, you must have valid documentation.
Learn MoreFind your way through a complicated EU marketplace with the support of a professional.
Learn MoreWhy Obelis?
- Since 1988
- Established in Belgium, Brussels
- The largest consultancy centre in Europe
- Solid international reputation
- Dedicated team of Experts ready to support you (Lawyers, Chemists, Pharmacists, Researcher, Scientists and others)
- Qualified & knowledgeable personnel
- Strong international presence
- Certified ISO 9001 & ISO 13485
- Active member of EU Associations and EU Commission Committees and Working Groups
- Chairman and Founder of E.A.A.R. (European Association of Authorized Representatives)
- Well-known organizer of international Seminars & Workshops (www.obelisacademy.com ) in cooperation with Authorities worldwide
- Strong network able to provide Obelis Clients with local regulatory solutions in 20+ markets worldwide
- Broad spectrum of services
Obelis is the sixth consulting firm we have worked with and NONE can compare with the professionalism and knowledge your team exhibits.
Obelis is the Gold standard of EU Responsible Person's for brand owners in looking to successfully enter the EU Market
Latest News
- Faster access of IVDs on the French market
- AEMPS Information about market campaign control for sunscreen products
- UK’s Guidance on 3D printing of medical devices or component parts during the pandemic
- Labeling guidance for hydroalcoholic gels published by the Spanish Agency of Medicines and Medical Device (AEMPS)
- National MDR implementation – Germany’s establishment of NAKI
- Coronavirus: updated guidelines for verifying the compliance and suitability of surgical face masks