Obelis European Authorized Representative Center (O.E.A.R.C.)

Global Solutions in One Convenient Location

OneLink:OneSolution is a comprehensive solution to the regulatory needs of manufacturers worldwide. This program offers an exceptional association of experts who provide a myriad of services, to include superior regulatory and directive assistance and consultation, language compliance solutions, and new market penetration strategies. Our members are already located in the European Union, the United States, Brazil, Canada, China, India, Israel, Australia, South Korea, and Malaysia, making your expansion into foreign markets simple and successful. Our network of companies involved with OneLink:OneSolution consist of the following:

Obelis European Authorized Representative Center (O.E.A.R.C.) is a quality-driven, service-oriented company located in Brussels, Belgium. With over 17 years of proven experience, O.E.A.R.C. offers full regulatory services as an EC REP to non-European and non-U.S. medical device manufacturers desiring to sell in European and U.S. markets.

The Qserve® Group has offices in the Netherlands and in the United States. Qserve is an independent consulting firm providing quality management system implementation, product market approval, and regulatory services for medical device manufacturing companies worldwide.

Net-Translators is an established multi-national translation company located in Israel. They specialize in software localization, including GUI, online help, and documentation in over 40 languages. Hundreds of medical device manufacturers have benefited from Net-Translators expertise in translation solutions.

Advanced Compliance Engineering Services (ACES) helps manufacturers and exporters to comply with global market regulations. ACES is located in California and through years of experience has developed a complete understanding of both technical and commercial regulatory environments enabling them to provide manufacturers with accurate regulatory tests and certifications.

EG Mont Assessoria Operacional is a Brazilian services company that specializes in providing medical and dental device companies with high quality, simple, and successful solutions to product manufacturing, quality, and operational problems. EG Mont focuses on assisting clients in entering the international markets.

McCarthy Consultant Services Inc. is a leader in the world of Canadian regulatory affairs for the medical device, pharmaceutical, biotechnology, food, and cosmetic industries. The skilled and knowledgeable associates of McCarthy specialize in regulatory strategic planning, labeling and advertising reviews, and quality systems audits.

MDC Associates is committed to working closely with clients, providing affordable and effective market research and regulatory consulting services with over 30 years of combined experience in both the medical device market and the regulatory environment. MDC is located in Massachusetts and offers a unique combination of services that help clients develop successful marketing strategies.

Robinson Medical Marketing Services Ltd. located in Israel, provides international marketing coverage and representation to top tier Israeli manufacturers with a special emphasis on emergency medicine. Robinson Medical acts as an external export department offering support and consulting services in marketing, technology, documentation, and CE Marking.

Symbiotic Research Pty. Ltd. combines two established service providers, Delpharm Pty. Ltd. And Innovation Dynamics Pty. Ltd. Together the partners offer a full range of regulatory and business development services to the medical device, pharmaceutical, agro-veterinary, and biotechnology industries. Located in Australia, Symbiotic Research is based in Sydney and provides a comprehensive understanding of the industries in the region.

Synex Consulting Korea is the first company of its kind to introduce strategic and regulatory consulting services for Korean domestic and worldwide medical and pharmaceutical firms. Synex seeks to be the advisors of choice for their foreign consulting partners and industry customers to keep their competitive edges in their various business domains.

Unikal Consultants is a leading consulting and integrated service provider based in Ahmedabad, India. Unikal specializes in CE Marking, ISO Quality Managements System implementation, auditing documentation, WHO-GMO Certifications, and chemical and medical technology consulting.

Together, the OneLink:OneSolution network offers complete solutions to medical device manufacturers.

To learn more about OneLink:OneSolution and to speak with our representatives about this program please visit us at Medica 2005 in Hall #13, Booth #A14.

For additional information regarding OneLink:OneSolution please visit the Obelis website at http://www.obelis.net/Services/onesolution/onelinkonesolution.html.

Obelis, s.a. O.E.A.R.C.
34 Avenue de Tervuren, Bte 44
B-1040 Brussels, Belgium
Telephone : +(32) 2 732-5954
Fax : + (32) 2 732-6003
Email : mail@obelis.net