We Introduce Ourselves

Our history begins in 1988, when our CEO, Mr Gideon Elkayam, founded Obelis and made his dream of “creating compliance for safer markets” come true. Over the years, this unique vision has helped us build a remarkable standing in our field of specialization by turning us into the most significant center for regulatory services in Europe. And being based in Brussels, at the European Union’s center, has allowed us able to collaborate with the EU institutions regularly and swiftly.

Today, we can say that we have played our role in shaping the EU compliance industry. But our journey did not lead us astray from our original goal: every day, we continue to support our worldwide clients in navigating the regulatory maze. In three decades, we have worked with more than 3.000 manufacturers from over 60 countries.

But what is it that makes us so special? The fact that we see ourselves not only as your Consultant on EU regulations but also, and firstly, as a partner whose purpose is to help your business grow.

Obelis Group stays by your side on your journey into and across Europe.

Our Values

On regulatory level, Obelis is committed to sustainable compliance and product safety in Europe.

But also within our own ranks do we treat our values seriously. It is thus that we provide both our clients and ourselves with a competitive edge.

Obelis demonstrates leadership and a strong commitment to sustainable compliance and safety in the EU. As a company, we take pride in acting with an owner mentality, passion about what we do, and seizing opportunities and welcoming responsibility. We are alert to change and meet the challenges that arise in a quick and decisive manner. That way, we provide ourselves as well as our clients with a competitive edge.

At Obelis, we deliver on our promises and pride ourselves on going the extra mile, adding value that goes beyond the usual standards. Our ways of working and making decisions, as well as our compliance with procedures, ensures we have the freedom to shape our own future.

We learn by developing and deepening our knowledge of our business day by day. We listen to each other, to clients and advisors, we capture and share this knowledge, and apply the lessons learnt from successes and failures.

At Obelis, each individual inspires trust as we match behaviour with words and take responsibility for actions. We collaborate in the best interests of our clients by acting as leaders, because we believe that we all play a leadership role. It is defined by courage and personal integrity, as well as having the vision and positive attitude to inspire and motivate others.

We believe that working with people from different backgrounds, cultures and ways of thinking helps our teams grow into better professionals and leaders. As a company, Obelis is committed to diversity and unique contributions, to a trusting, open and inclusive environment, and to treating each person in a manner that reflects these values.

We believe in behaving with the highest levels of integrity – nothing is more important than our reputation. In a business that relies on integrity, honesty and accountability, being trustworthy, honorable and responsible is a fundamental part of who we are.

Team

Meet the dynamic team creating compliance for safer European markets. The Obelis team is led by a Board of Directors that brings decades of professional expertise in Regulatory Affairs and Quality Assurance within the European Union. To help us work towards the mission “To be the consultant of choice by shaping the compliance industry and providing the most effective compliance process”, we’re supported by an Advisory Board.

This is comprised of several accomplished experts with extensive experience in Regulatory Affairs, medical technology, lobbying, business management, marketing and organizational development.

Last but not least, we have our team of Managers & expert consultants facilitating compliance and entry onto the European market for manufacturers in multiple sectors from medical devices and cosmetics to consumer goods.

Board
Managers
Advisory board

Partners

While Obelis core services are exclusively focused on the EU Market allowing us to maintain a high-level of services and expertise towards the EU Market, our clients have the additional benefit of gaining access to our world-renown Obelis International Offices (OIO) Network.

Obelis International Offices are independent partners who are able to provide our clients with solutions offering the same level of expertise and professionalism in other global markets of their choosing. Each partner will be able to provide an independent quotation of their service relevant to the local requirements. Obelis International Offices (OIOs) are located around the world, in 11 different countries. This provides a powerful international network. If you’re having trouble understanding or meeting EU regulations for selling your products in Europe, there is a representative near you who can explain and advise what you need to do in your language.

A dedicated European Authorised Representative is required for any non-European manufacturer who wants to sell their medical devices in the EU. Through our network of OIOs, we can provide you with:

  • High-quality, personal services tailored to your specific compliance needs
  • Easy access to regulatory solutions and support from within the market
  • The same commitment to quality, standards and values that you’d receive from our headquarters in Brussels
  • Dedicated training and ongoing support from our expert team of regulatory consultants
Become a partner
Brazil

EG MONT
Rua Cerqueira César, 1625
Jd. Sumaré – CEP 14025-120
Ribeirão Preto – SP – Brazil
E-MAIL: eduardo@egmont.com.br
TEL: 0055.16.3969.5154
MOBILE: 0055.16.9961.2003
FAX: 0055.16.3969.5154

Canada

PASB Technical Solutions Inc.
6 Berrigan Place
St. John's NL A1B 1Z9 - Canada
E-MAIL: paul.bassler@pasbtech.com
TEL: 001.709.699.6113

China

AccuService
No. 2, Kecheng Road, Suzhou Industrial Park
215211, China
E-MAIL: info@accu-group.com
TEL: +86 (0) 512 8227 2260
MOBILE: +86-18994308901

Egypt

letqan
El-Nasr st, New Nozha, 1
Cairo - Egypt
E-MAIL: ashahean@ietqan.com
MOBILE: 00201.68.843.664
FAX: 00202.262.161.74

India

Unikal Consultants
Goyal Plaza, F/6
Nyay Marg, Vastrapur
380015 Ahmedabad - India
E-MAIL: sanjay@unikalindia.com
TEL: 0091.982.401.7850

Korea

Chemron FDA
506, Youngchang B/D
663 Seolleung-ro
Gangnam-gu (Zip: 135-830), Seoul, Korea
E-MAIL: gracejschem@hotmail.com
TEL: 0082.2.568.7744
MOBILE: 0082.10.5713.3060

Malaysia, Indonesia and Vietnam

KMLoi
Jalan USJ 9/5Q, 27-3
47620 UEP Subang Jaya, Selangor
Malaysia
E-MAIL: kmloi@streamyx.com
TEL: 0060.12.303.6757

Mexico

Terceros en Servicios de Riesgos Sanitarios, S.A.P.I. de C.V
1181 Revolution avenue, Floor PH,
Mexico City - Mexico 03930
E-MAIL: fibanez@tesiscv.com
TEL: 0052.15.5565.12900

Pakistan

Track International
Syed Raza Ullah Shah
10 43 A Citi Housing, Daska Road, Pakistan
E-MAIL: razashah801@gmail.com
TEL: 0092.3216.1435.74

Asia and USA

medicalregs.com
Angeles City, Pampanga, Philippines
E-MAIL: michael.wetherington@medicalregs.com

Taiwan

LC & P Limited (MDD)
Mr. Eric Leung
2/F, No.392, Road Xinyi Dist, Taipei City 11050
E-MAIL: eric@lcpartner.hk
TEL: 00.886.2.2758.8892

Taiwan

UNIQUE MANAGEMENT CONSULTANTS CO. LTD. (COS)
Mr. Darren Chiu
No. 105, Sanmin W. Rd., West Dist, Taichung City 403
E-MAIL: chiu0637@gmail.com
TEL: 00.886.4.2375.9100

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Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
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