A Singapore company is looking to provide its language translation, and medical product registration services to European medical devices, life science and pharmaceutical companies seeking to enter or expand in Asia.

Center name Тестовый центр
Summary This Singapore company is an ISO 9001:2015 and ISO 13485:2016 certified company. Based in Singapore this company is looking to provide medical translation and product registration services to pharmaceutical companies, medical device manufacturers, clinical research organizations, laboratories, medical logistics specialists, and professional services firms from Europe through a services agreement.
Description of the offer Established in Singapore, this company serves many Multi National Corporations (MNCs) across the life sciences industry, pharmaceutical, biotech, medtech, Contract Research Organizations (CRO), medical laboratories, supply chain, tradition chinese medicine (TCM), complementary medicines, cosmeceutical organizations, and related professional services providers such as market research, consulting, intellectual property and legal organizations. Services provided as such:: 1. Medical and life sciences translation End-to-end certified language translations from/to more than 12 Asian languages (e.g. Chinese, Japanese, Korean, Indonesian, Malay, Hindi, Urdu, Parsi, Thai, Bengali, Tamil, Vietnamese, etc.), a. Certified translations for medical device companies: operating manuals, regulatory applications, packaging inserts & labels, datasheets, marketing materials b. Certified translation for pharmaceutical companies: Product labelling, clinical data, regulatory submissions, research articles, expert marketing collateral c. Certified translations for Contract Research Organizations (CRO), patient diaries, safety reports, Institutional Review Board (IRB) correspondences, study reports, site contracts. d. Translation and local adaptation of medical documents for: Clinical Research (informed consent forms, protocols, abstracts, etc.) Regulatory Affairs for Serious Adverse Events/Adverse Events (SAE/AE) reports, Periodic Safety Update Report (PSUR) reports, new drug applications, drug formulation, etc. …) e. Marketing collaterals for websites, press releases, newsletters, etc. f. Corporate functions such as contracts, business communications, training materials, etc. 2. Medical Writing For commercial, scientific and regulatory research, and produce materials such as product brochures, opinion articles, presentation decks and blogs. 3. Product Registration Preparatory services for regulatory submission, advisory, road map planning and coordination in the ASEAN region, South Korea and Hong Kong markets. This company is seeking to expand in Europe through a services agreement. to provide medical translation and product registration services to pharmaceutical companies, medical device manufacturers, clinical research organizations, laboratories, medical logistics specialists, and professional services firms.
Advantages and Innovations 1. Proven track record Achievements in the last 12months: • Sole global provider for Asia Biotech of the Year 2015-2016 • Collaboration partner with 4 of the Top10 global Contract Research Organizations (CRO) in Asia. • Collaboration partner for #1 Japanese CRO • Sole global provider for #2 Japanese CRO 2. Quality focus and risk management This company is certified for compliance with ISO 13485:2016 and ISO 9001:2015. 3. Management team The management team and consultants draw on decades of experience leading life sciences companies and professional services companies in the life sciences sector around Asia. 4. Technology a. Translation service is managed through ERP in the cloud, and quotation processing is fully automated, giving the fastest response times to customers in the market. b. Customers can access portal where they can view project data (spend, completion, category breakdown) in real-time. c. Customers with high translation needs can use this company’s proprietary translation API, and integrate into their IT platforms with to simplify and accelerate translation for their users. 5. Customer service and communications The team operates till 1300hrs CET daily; this is to provide close support for Europe-based customers.
Market Keywords 05007007 Other medical/health related (not elsewhere classified)
Type of Partnership Required Services Agreement
Type and Role of Partner Sought European companies from the Life Sciences industry, who are: a) either already operating actively in Asia and other regions, and would like to streamline or scale their operating activities (translation/content/registration) while driving cost optimization, through a trusted life sciences professional services partner b) or, looking to expand into Asia and other regions, and would benefit from translation/content/registration support from a trusted life sciences professional services partner through a services agreement. c) Looking to appoint a partner or sales representative in Europe Ideal partner should be an existing service provider with current coverage in Europe in the medical or life sciences industry. The ideal partner could be a contract research organization (CRO), market research firm, consulting firm, events & conferences producer, regulatory/registration consultancy, intellectual property or legal firm.
Date of creation 13.04.2018
Profile type Business offer
Profile openness to interact N
Profile from EEN Y

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