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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
Em um mercado que rapidamente muda e no ambiente das regulamentações das indústrias de dispositivos médicos e elétricos, a capacidade de …
Read more: EG Mont
India: Unikal Consultants
[ A-219, Shivam Towers (Popular Plaza) Someshwara Complex I,132 ft. Road, Satellite, Ahmedabad 380 015 India ]
t. +91 26 76 4548
Unikal Consultants, based in Ahmedabad, India, is a leading consulting and integrated service provider with over 25 years of regulatory experience …
Read more: Unikal Consultants
China: Accuservice
[ 377 ChenHui Road, Building 23, Zhangjiang, Pudong, Shanghai 201203 ]
t. +86 800 819 2228
AccuService is a quality control management service that bridges the gap between international companies and manufacturers. We will immerse ourselves in …
Read more: Accuservice
Thailand: Superb Quality Service Co., Ltd.
[ 102/167 Moo 2 Rattanathibet Road, Saimar Muang Nonthaburi 11000 ]
t. +66 02921 7828
Superb Quality Services Co., Ltd. is a dynamic consulting firm conducting consulting and training on ISO 9000, 14000, 22000, ISO/TS16949, OHSAS …
Read more: Superb Quality Service Co., Ltd.
Malaysia: Globiz Management
[ 11 Lebuh Perajurit 3,Ipoh Garden East,31400 Ipoh, Perak, Malaysia ]
t. +60 12 501 0066
Globiz Management, a Malaysian company provides management services and training for Quality Management Systems for Medical Devices, Product Certification / Registration, …
Read more: Globiz Management
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
IRC offers a complete range of services which include highly important strategic regulatory business planning. IRC maintains strategic operations to help …
Read more: International Regulatory Consultants, L.C.
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
QualityWorks Consultancy Corp. provides management consultancy and training services relating to global international standards like Quality Management Systems, Healthcare, Information Security, …
Read more: Quality Works Consultance Group
USA: Advanced Compliance Engineering Services
Advanced Compliance Engineering Services (ACES) helps manufacturers and exporters to comply with global market regulations. Through many years of experience, ACES …
Read more: Advanced Compliance Engineering Services
Canda: McCarthy Consultant Services Inc
[ 1151 Gorham Street, Unit #8 Newmarket, Ontario L3Y 7V1 Canada ]
t. +1 905 836 0033
MCSI is a leader in the world of Canadian regulatory affairs for the Medical Device, Pharmaceutical, Biotechnology, Food and Cosmetic industries. …
Read more: McCarthy Consultant Services Inc
Australia: Symbiotic Research Pty Ltd.
[ Suites 403 & 404, 200 Pacific Highway Crows Nest, Sydney NSW 2065 Australia ]
t. +61 2 9956 6122
Symbiotic Research Pty Ltd. combines two established contract service providers, Delpharm Consultants Pty Ltd. and Innovation Dynamics Pty Ltd. Together, the …
Read more: Symbiotic Research Pty Ltd.
Israel: Mediclever
Mediclever manages end-to-end reimbursement projects for medical device companies, selling their products in the US and Europe.
We identify availability …
Read more: Mediclever
USA: MDC Associates
MDC Associates is committed to working closely with clients, providing affordable and effective market research and regulatory consulting services with over …
Read more: MDC Associates
China: Osmunda Management Consulting Co., Ltd.
[ 1/F., No.4Building,GD Province Quality & TSB Office,No.563 Nantian Road,Haizhu District Guangzhou 510220 P.R.C China ]
t. +86-20-3761 2981
广州西思特技术服务有限公司是从事质量认证/合格评定咨询、产品检验/产品改进咨询等技术服务的机构。公司拥有经验丰富、素质良好的工作队伍，迄今已向100多家企业提供认证咨询服务，使企业成功获得认证证书以及提高自身质量管理素质。具备各类型管理体系认证、产品认证咨询服务的优势，可为广大客户提供快捷便利、专业高效的咨询辅导服务，如管理体系文件的编制和修订辅导、管理体系的贯彻执行辅导、内审辅导、人员培训、标准培训等
GuangZhou Osmunda Management Consulting Co., Ltd.
广州市奥咨达管理顾问有限公司是专业从事医疗器械管理体系认证和产品认证的咨询公司，同时为中国境外的医疗器械制造商提供进入中国市场的产品注册代理和境外企业在中国的OEM制造商的工厂审核服务。公司与国际和中国认证机构有着长期友好的合作关系，公司的客户包括国内外众多著名医疗器械生产厂家和进出口贸易公司。
Read more: Osmunda Management Consulting Co., Ltd.
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