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Obelis Scientific Department Officially Launched!
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On 1st September 2016, Obelis officially launched a new department within the company structure - the Scientific Department. It makes up part of the Compliancy Unit and complements the pre-existing R [...]

Representatives

Australia

in Representatives

RQSolutions

1F/1 FRANCIS ROAD, ARTARMON NSW 2064, AUSTRALIA.
E-MAIL: admin@rqsolutions.com.au
TEL: 0061.413.578.665
MOBILE: 0061.2.9413.2850
FAX: 0061.2.9413.2852

RQSolutions has over 25 years of experience in product registrations and quality management within the healthcare industry. Working closely with the Australian Therapeutic Goods Administration and other local industries, they specialize in first time product registration and ongoing compliance. Services from RQSolutions include:

  • Registrations
  • Quality compliance
  • Document management
  • Medical device directives
  • Regulatory intelligence, training and up-skilling

Brazil

in Representatives

EG Mont Brazil

RUA MODESTO JUNGUEIRA 186, 14076-120 RIBEIRÃO PRETO-SP- BRASIL.
E-MAIL: eduardo@egmont.com.br
TEL: 0055.16.3969.5154
MOBILE: 0055.16.9961.2003
FAX: 0055.16.3969.5154

EG Mont specializes in market regulation for medical devices and electrical products. Their services cover the entire journey and include advice and guidance throughout the production process (pre, during and post) as well as:

  • Pre-shipment
  • Factory audits
  • Lab testing
  • Product component inspections

China

in Representatives

AccuService 


8/F, Weiting science and innovation park
Weizheng Road No.8
SIP Suzhou, Jiangsu, China
E-MAIL: sabrina_yu@accu-inspection.com; elvis_zhao@accu-inspection.com
TEL: +86 0512-82272260
FAX: +86 0512-68056420

AccuService is a quality control management service that bridges the gap between international companies and manufacturers. With over 1000 employees in more than 30 service centers spread throughout China, Malyasia, Singapore and Southeast Asia, AccuService offer a range of services including:

  • Component inspections
  • Pre and post production inspections
  • Shipment supervision

Egypt

in Representatives

Ietqan

1 EL-NASR ST, NEW NOZHA, CAIRO, EGYPT.
E-MAIL: Heldebeky@ietqan.com
MOBILE: 00201.68.843.664
FAX: 00202.262.161.74

Ietqan is a consultancy company with an encyclopaedic knowledge of medical device directives and the medical industry as a whole. With over 15 years of experience in handling blood lines, dialyzers, surgical dressings and a range of other medical products, Ietgan offer a variety of CE mark services, including CE compliance, consultation and training. Other services include:

  • Management system preparation
  • Technical file preparation
  • ETO sterilization validation
  • Clean room validation

India

in Representatives

Unikal Consultants

F/6 GOYAL PLAZA, JUDGES BUNGALOW ROAD, VASTRAPUR, AHMEDABAD 380015, INDIA.
E-MAIL: sanjay@unikalindia.com
TEL: 0091.982.401.7850

Unikal Consultants have a wealth of regulatory experience with regards to CE marking, particularly for chemical and medical technologies and products. They have been helping clients for over a quarter of a century and their services include:

  • Management systems
  • CE certification
  • Technical file preparation
  • Audits and document management
  • ISO 9000 & Quality
  • ISO 13485

Japan

in Representatives

Cosmos

718-1 KATSURASE-CHO, MATSUSAKA-SHI, MIE-KEN 515-1104, JAPAN.
E-MAIL: morimoto-yu@cosmos-corp.com
TEL: 0081.80.3439.9456
FAX: 0081.598306631

Cosmos focuses on compliance and declaration of conformity services for electric components. They offer comprehensive safety assessments which include:

  • Visual inspections
  • Product testings
  • Electromagnetic Compatibility (EMC) measurements
  • ISO 9001 & 14001 certification

Korea

in Representatives

CHEMRON FDA KOREA Co., Ltd.

#506, YOUNGCHANG B/D, 663 SEOLLEUNG-RO, GANGNAM-GU, SEOUL, KOREA (ZIP: 135-830).
E-MAIL: gracejschem@hotmail.com
TEL: 0082.2.568.7744
MOBILE: 0082.10.5713.3060

Chemron provide services regarding the certification and testing of cosmetic products, medical devices, foods and consumer goods. Their services include:

  • Ingredient analysis
  • Testing guidance
  • Conformity assessments
  • Clinical investigations

Malaysia – Philippines – Indonesia – Vietnam

in Representatives

KM Loi & Associates Sdn. Bhd.

NO 27-3, JALAN USJ 9/5 Q, SUBANG BUSINESS CENTRE, 47620 UEP SUBANG JAYA, SELANGOR DARUL EHSAN.
E-MAIL: kmloi@streamyx.com
TEL: 0060.12.303.6757

KM Loi & Associates Sdn. Bhd offer expert consultancy and advisory services for manufacturers. They provide efficient, practical business solutions and services for a range of Quality Assurance Directives, including:

ISO 9001:2008; SA8000:2008; ISO/TS 16949:2002; ISO 15189:2003; ISO 13485:2003; ISO 14001:2004; ISO 22000:2005; ISO/IEC 17025:2005; OHSAS 18001:2007; MS 1500:2004; MS 1722:2005; MS 1900:2005


Mexico

in Representatives

DISPOMED

AVE. División del norte 2723 PH Col. San Lucas Del. Coyoacán. CP. 04030 México DF.
E-MAIL: folivares@dispomed.mx
TEL: 0052.55.5549.5961
MOBILE: 0052.1.552.095.0882

Dispomad has over 20 years of experience in quality assurance and health regulations, particularly within the pharmaceutical industry. Dispomad specialize in CE marking and medical device directives for Europe. Their services include:

  • Quality systems implementation under the Schemes of Good Manufacturing Practices (COFEPRIS), Good Manufacturing Practices (FDA), RDC No. 59 ANVISA (BRAZIL), ANMAT (ARGENTINA), ISO 9001, ISO 13485, CE MARKING and European Medical Directives (EUROPE) and other Health Systems and Regulation both Nationally and Internationally.
  • Quality system audits
  • Training in quality systems and health regulations
  • Medical device distribution
  • Preparation of Documents for Specialized Translations
  • Documentation Preparation of Dossiers for Class I, II or III (COFEPRIS, FDA), I, IIa, IIb and III (European Scheme), I, II, III and IV (Canada and Brazil)
  • Medical Devices Distribution in Mexico

Pakistan

in Representatives

R. Plus Unique Systems

Syed Raza Ullah Shah
16 First Floor Sethi Plaza Sialkot, Pakistan.
E-MAIL: razashah801@gmail.com
TEL: 0092.300.616.4428

R. Plus Unique Systems boast a team of experts across a range of fields and offer consultancy services for a variety of quality management system standards and CE marking. Their services include:

  • Good Manufacturing Practice (GMP)
  • Code of conduct audits
  • Pre-shipment inspection services
  • CE marking
  • ISO 9001
  • ISO 13485
  • ISO 14001
  • ISO 22000
  • SA 8000
  • OHSAS-18001
  • HACCP
  • GMP

UAE – Saudi Arabia – Kuwait – Jordan

in Representatives

RACS

OFFICE 202, KHALIFA SAID AL MIRRI BUILDING, HOR AL ANZ, DEERA, DUBAI, P.O. BOX: 252480, UAE.
E-MAIL: hjamal@racs-me.com
TEL: 00971.4.23.88.755

Logo_OIO_RACS

 

RACS is the primary provider of services for regulatory affairs in the Middle East. They work with companies looking to launch medical, cosmetics, biotech, toys and electrical products, amongst others, in the region. Services include:

RACS General Services

  • Legislation interpretation (Products, Practices)
  • Ingredients Reviews
  • Classifications (Borderline Products)
  • Labeling Compliance as per directives
  • Product Information File (PIF) Review
  • Representing in front of Authorities-communications Written and Physical
  • Providing updates on changing regulatory and guidance through these changes
  • Preparations of registrations files
  • Submissions
  • Follow up registration files
  • Submissions
  • Follow up, registrations, transfers & renewal registration
  • Minor Changes (Company, Manufacturer and Product)
  • Marketing Materials Assessments lab analysis, lab tests
  • Safety Evaluation (Products, Ingredients)
  • Clinical Studies reviews and filtering
  • Medical Translation

 

Regulatory Affairs and Consultancy Services

  • Regulatory Affairs Consultancy
  • Products Registration
  • Company & Manufacturer’s Registration
  • Controlled Storage
  • Ingredients Screening
  • Finished Product Evaluation)
  • In House QA
  • Process Validation
  • Agent Representation
  • Packaging Development
  • Packaging Compliance
  • Labeling Compliance & Translation
  • Conformity Certification
  • Method Validation
  • Market Studies (Statistics, Data filtering)
  • Project Management
  • New product developments (Launching Strategies, 4ps, etc.)