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One Link, One Solution For the Mutual Benefit of the Mutual Clients

Obelis is excited to announce the latest OneLink OneSolution advancement. While still retaining the core group of international compliance experts, OneLink OneSolution will begin the process of expanding its boundaries beyond the current service offerings which include regulatory services, language compliance solutions, and new market penetration assistance companies.

OneLink OneSolution will now include businesses from a variety of fields, including marketing, distribution services, public relations, technical writing, and internet marketing. These companies will be carefully selected to ensure they maintain the same superior standard as current OneLink OneSolution members.

This diversification process will allow customers seeking different types of services or products to locate trusted and high-quality suppliers quicker and with more confidence. As always, the OneLink OneSolution group is dedicated to ensuring new members are the best in their respective fields and geographic locations.

As OneLink OneSolution is continually expanding, please check the Obelis website regularly to check out new group members and the latest high quality services being offered.

Solutions include:

Expertise in chemical and medical technology consulting
Market research to maximize product potential
European Authorized Representative Services for all 27 member states
FDA/ISO Regulatory Consultation
Preparation and 510(k) documentation for pre-market submissions
Continual monitoring of regulatory compliance
Consultation for CE Mark approval
Identification of language compliance/translation requirements
Access to the Australian module of the IDRAC web service
Translation management for all inserts, labeling, and product materials
Ongoing language maintenance and glossary development
Preparation and submittal of the Notification file for the EU
IVD and MDD Regulatory, Consultation, Notification, and CE-Marking Services
Call Center to provide customer support
Access to international network of experts
Presentation of Current & Relevant Reimbursement Status, Reimbursement Strategic Planning Reimbursement Plan Implementation, Health Economics

Brazil: EG Mont

[ Rua Modesto Jungueira 186, 14076-120 Ribeirão Preto-SP- Brasil ]

t. +55 16 3969 5154

e. egmont@egm ...

Em um mercado que rapidamente muda e no ambiente das regulamentações das indústrias de dispositivos médicos e elétricos, a capacidade de …

Canada: McCarthy Consultant Services Inc

[ 1151 Gorham Street, Unit #8 Newmarket, Ontario L3Y 7V1 Canada ]

t. +1 905 836 0033

e. mccarthy@m ...

MCSI is a leader in the world of Canadian regulatory affairs for the Medical Device, Pharmaceutical, Biotechnology, Food and Cosmetic industries. …

China: Osmunda Medical Device Consulting Co., Ltd.

[ Unit 215, 8th Building, No. 56 Shuiyin Road, Guangzhou, Guangdong, 510075, P.R.C. China ]

Vivian Pan

t. +86-20-3761 2981

e. osmunda@os ...

China Osmunda Medical Devices Consulting Co., Ltd. (Guangzhou, Shenzhen, Suzhou, Wuhan, Xiamen) is engaged in medical device quality management system certification …

USA: International Regulatory Consultants, L.C.

[ Mid Valley Professional Plaza 7651 S. 700 West, Suite 105 Salt Lake City, Utah 84047-7101 ]

Donald F. Grabarz

t. +1 801 233-0075

e. info@irclc ...

IRC offers a complete range of services which include highly important strategic regulatory business planning. IRC maintains strategic operations to help …

India: Unikal Consultants

[ F/6 Goyal Plaza, Judges Bungalow Road, Vastrapur, Ahmedabad 380015, India ]

Sanjay Shah

t. +91-79-26744219

e. info@unika ...

Unikal Consultants, based in Ahmedabad, India, is a leading consulting and integrated service provider with over 25 years of regulatory experience …

Malaysia: KM Loi and Associates

[ No:27-3, Jalan USJ 9/5 Q, Subang Business Centre, 47620 UEP Subang Jaya, Selangor Darul Ehsan ]

Dr. K.M. Loi

t. +6012-303 6757

e. kmloi@kmlo ...

KM Loi & Associates Sdn. Bhd. (669057-A) is recognized as a leading management system standard expert in management consultancy and technical …

Egypt: Ietqan for Consultancy

[ 1 El-Nasr st, New Nozha, Cairo, Egypt ]

Kareem Aboul-Fadl

t. +(202) 262-16174

e. ietqan@iet ...

Ietqan for consultancy is company working in the field of consultation with core competence of the medical devices industry. Ietqan team …

Egypt: Qualitech International

[ 1st Floor, Building 137, El-Bishaaier District 6th October City 12566, Egypt ]

e. www.qt-int ...

Qualitech international is an Egyptian based leading consulting firm; The only specialized consulting firm in Egypt in the field of Medical …

Korea: CERMET Asia Ltd.

[ Yonghyun BD. 50-1, Yonggang-dong, Mapo-gu, Seoul, Korea ]

Mr. Hong Yoon / Product Certification Manager

t. Tel.82-2-704-9043

e. hyoon@cerm ...

CERMET Asia Ltd. was founded in 2003 as Korean branch of Italian certification body, and keeps our position as a foreign …

Russia: CQC and Timesert

[ Saint-Petersburg ]

Ivanov Dmitry

t. +48509959591

e. dima@certi ...

CQC assists on certifying goods exported to Russia. CQC works jointly with Timesert in Russia for all regulatory and testing services. …

Singapore: Spade Consultancy

[ 22A Ann Siang Road, Singapore 069702 ]

t. +65 62842918

e. enquiry@sp ...

SPADE Consultancy Pte Ltd is setup to provide Speedy, Precise, Accurate, Dynamic and Excellent testing and certification services to clients who …

China: EXCEL PharmaStudies Inc.

[ Suite 2003-6, North Ring Center, No.18 Yumin Road, Xicheng District, Beijing 100029, China ]

Bill Wang

t. +86 (10) 8225-0022 Ext.157

e. bin.wang@e ...

Excel is a full-service provider of registration, clinical research, biometrics, and training and consultation services. Excel is the leading CRO in …

Australia: Symbiotic Research Pty Ltd.

[ Suites 403 & 404, 200 Pacific Highway Crows Nest, Sydney NSW 2065 Australia ]

t. +61 2 9956 6122

e. info@symbi ...

Symbiotic Research Pty Ltd. combines two established contract service providers, Delpharm Consultants Pty Ltd. and Innovation Dynamics Pty Ltd. Together, the …

Israel: Mediclever

[ 3 Tolkovski St.Tel-Aviv 69358, Israel ]

t. +972 50 837 1711

e. info@medic ...

Mediclever manages end-to-end reimbursement projects for medical device companies, selling their products in the US and Europe.
We identify availability …

USA: Advanced Compliance Engineering Services

[ 670 National Avenue, Mountain View, CA 94043 ]

t. +1 650 631 7625

e. info@gotoa ...

Advanced Compliance Engineering Services (ACES) helps manufacturers and exporters to comply with global market regulations. Through many years of experience, ACES …

Philippines: Quality Works Consultance Group

[ Unit 223, Chateau Verde CondominiummGate 2, Valle Verde 1, E. Rodriguez Jr. Ave. (Along C-5)mBrgy. Ugong, Pasig City 1605 ]

t. +632 671 4859

e. Jocelyn.de ...

QualityWorks Consultancy Corp. provides management consultancy and training services relating to global international standards like Quality Management Systems, Healthcare, Information Security, …

China: Accuservice

[ 377 ChenHui Road, Building 23, Zhangjiang, Pudong, Shanghai 201203 ]

t. +86 800 819 2228

e. info@accus ...

AccuService is a quality control management service that bridges the gap between international companies and manufacturers. We will immerse ourselves in …

Thailand: Superb Quality Service Co., Ltd.

[ 102/167 Moo 2 Rattanathibet Road, Saimar Muang Nonthaburi 11000 ]

t. +66 02921 7828

e. consultsqs ...

Superb Quality Services Co., Ltd. is a dynamic consulting firm conducting consulting and training on ISO 9000, 14000, 22000, ISO/TS16949, OHSAS …

USA: MDC Associates

[ 163 Cabot St.Beverly, MA 01915 ]

t. +1 978 927 3808

e. info@mdcas ...

MDC Associates is committed to working closely with clients, providing affordable and effective market research and regulatory consulting services with over …