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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
Egypt: Qualitech International
[ 1st Floor, Building 137, El-Bishaaier District 6th October City 12566, Egypt ]
t.
Qualitech international is an Egyptian based leading consulting firm; The only specialized consulting firm in Egypt in the field of Medical …
Read more: Qualitech International
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
Canada: 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
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
China Osmunda Medical Devices Consulting Co., Ltd. (Guangzhou, Shenzhen, Suzhou, Wuhan, Xiamen) is engaged in medical device quality management system certification …
Read more: Osmunda Medical Device Consulting Co., Ltd.
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.
India: Unikal Consultants
[ F/6 Goyal Plaza, Judges Bungalow Road, Vastrapur, Ahmedabad 380015, India ]
Sanjay Shah
t. +91-79-26744219
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
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
KM Loi & Associates Sdn. Bhd. (669057-A) is recognized as a leading management system standard expert in management consultancy and technical …
Read more: KM Loi and Associates
Egypt: Ietqan for Consultancy
Ietqan for consultancy is company working in the field of consultation with core competence of the medical devices industry. Ietqan team …
Read more: Ietqan for Consultancy
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
CERMET Asia Ltd. was founded in 2003 as Korean branch of Italian certification body, and keeps our position as a foreign …
Read more: CERMET Asia Ltd.
Russia: CQC and Timesert
CQC assists on certifying goods exported to Russia. CQC works jointly with Timesert in Russia for all regulatory and testing services. …
Read more: CQC and Timesert
Singapore: Spade Consultancy
SPADE Consultancy Pte Ltd is setup to provide Speedy, Precise, Accurate, Dynamic and Excellent testing and certification services to clients who …
Read more: Spade Consultancy
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
Excel is a full-service provider of registration, clinical research, biometrics, and training and consultation services. Excel is the leading CRO in …
Read more: EXCEL PharmaStudies 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: 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
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
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.
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
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