Page 184 - MedTech 1920_29Oct
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SUPPORTING SERVICES
SINGAPORE MEDTECH DIRECTORY 2019/2020
Medical Translation Services – Cont’d
MEDIQTRANS PTE LTD – Cont’d
We perform certi ed medical translations for an extensive range of document types, including:
• CLINICAL RESEARCH: Informed consent forms, protocols, abstracts, investigator brochures, IRB correspondences, study reports, PIL (patient information lea ets), scales
• REGULATORY AFFAIRS: AE/SAE reports, PSURs, NDA
(New Drug Applications), MAA (Marketing Authorisation Applications), drug formulation, quality control documents
• PRODUCT INFORMATION: Design history  les, IFUs/DFUs, user & technical manuals, package inserts, labels, software UI strings
• MARKETING (online/of ine): Multilingual websites, mobile sites, presentations, press releases, newsletters, brochures & posters, e-books
• CORPORATE USE: Contracts, business communications, e-learning, training materials, employee surveys
As a trusted language translation partner of many world-leading organisations, we offer successful global market access for all companies in the medical sector. For enquiries please email to askme@mediqtrans.com
Research & Development
3-D MATRIX ASIA PTE LTD 9 Battery Road
11F MYP Centre
Singapore 049910
Tel: (65) 6408 3858 Fax: (65) 6408 3858
AGAPE-LIFE SUPPORT SYSTEM PTE LTD 7 Straits View
#05-01 Marina One East Tower Singapore 018936
Tel: (65) 8198 5110
Email: enquiry@agape-lifess.com Website: www.agape-lifess.com
Contact:
Dr Joalin Lim, Founder & CEO
Nature of Business:
Have a Medtech/HealthTech product you want to bring to Asia? Look no further...
Agape-Life Support System (a.k.a Agape-Life) puts the right people & plan in place to help manufacturers launch your healthtech/medtech products with speed and quality while complying with regulatory requirements.
We help develop the right strategic plan of action that takes into account your Company needs and goals. We put together a talented team of professionals who are each an expert in their  elds, to achieve your goals in a timely and effective manner.
All these, ultimately, is to ensure that you stay ahead of your competitors and achieve good brand reputation in the “non-transparent” regulatory environment of 18 countries in Asia market.
Our Services:
• Regulatory (strategy, operation)
• Quality compliance (gap analysis, ISO13485, CE/EU-MDR,
MDSAP audits etc)
• Clinical trial management (conduct clinical study, QA audit) • Reimbursement & health economic
• Market access (strategy, operation) and distributor search • IP management
• Concepts to prototype translation, R&D product via PDP to
commercialisation processes (including contract manufacturing management)
We cover 18 Asian countries:
• Greater China (Hong Kong, Taiwan, Macau) • ASEAN (10 countries)
• Japan
• S Korea
• Australia
• New Zealand
• India
• Bangladesh
• Sri Lanka
Registering a new Medical Device in the Asian Market is a complicated and drawn out process that can lead to a lot of frustration. The Agape-Life Registration Strategy helps companies wade through the complicated approval process so that you can get to market quickly in a cost effective manner.
ALCON PTE LTD
20 Pasir Panjang Road
#10-25/28 Mapletree Business City Singapore 117439
Tel: (65) 6722 6010
Fax: (65) 6235 8790
Member of SMF MTIG
ALLERGAN SINGAPORE PTE LTD
20 Pasir Panjang Road
#09-25 Mapletree Business City West Building Singapore 117439
Tel: (65) 6747 7077
Fax: (65) 6747 8289
Member of SMF MTIG
AMARANTH MEDICAL 41 Science Park Road #01-02 The Gemini Singapore 117610
Tel: (65) 6777 7225 Fax: (65) 6777 7478
ARQON PTE LTD
2985 Jalan Bukit Merah
#01-01C Singapore Manufacturing Federation (Education Wing) Singapore 159457
Member of SMF MTIG
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