About Us
Who we Are
Regat Unggul Sdn. Bhd. is a reputable healthcare solution provider established in 2014 as a Bumiputera company, registered under Companies Commission of Malaysia (SSM) & Ministry of Finance in Malaysia (MoF). Regat Unggul (RU) is a diversified Bumiputera company focused on improving people's lives through meaningful innovation. We strongly believe that Regat Unggul Biolife (RU-Biolife) as the division of healthcare & life science solution provider committed to deliver sustainable and compassion healthcare system that is available and affordable to everyone globally.
Recognition
Ministry of Finance Certificate
Ministry of Finance Certificate to supply medical equipments, Bumiputera Certificate to represent as Bumi Agent.
Our Global Partners Standard
We are highly committed to provide high quality healthcare and life science solution to the people we care. In RU-Biolife, all our products are manufactured at facilities which complies to international quality standard, recognised and certified by both local and international certification authority bodies. Our entire business modal are supported by global leading distribution and supply chain provider that delivers our products into the hands of end-consumers.
The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.
Conformitè Europëenne
(CE) Mark
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
ISO 13485:2016 - Medical devices - Quality management systems
ISO 9001:2015 specifies requirements for a quality management system when an organization: (1) Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements. (2) Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
ISO 9001:2015 - Quality Management Systems
Good manufacturing practice (GMP) is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. GMP is aimed primarily at diminishing the risks inherent in any pharmaceutical production, which may broadly be categorized in two groups: cross contamination/mix-ups and false labelling. Above all, manufacturers must not place patients at risk due to inadequate safety, quality or efficacy; for this reason, risk assessment has come to play an important role in WHO quality assurance guidelines.
WHO-GMP Certification
Our Vision
Develop and deliver innovative based solutions towards creating a vibrant society.
Our Mission
RU-Biolife aspires to :
1. Outstanding, recognised and valuable strategic partner in the procurement and supply of pharmaceutical products, medical devices & health solutions globally.
2. Promote timely access to quality and introducing innovative pharmaceutical solution addressing the diversified healthcare needs.
3. Committed to develop nutritional natural products that will improve and enhance the healthy lifestyle of people.
What we Deliver
RU-Biolife core business is focused in importing, exporting, warehousing, distribution & marketing of pharmaceutical drug products, medical devices, diagnostics, vaccines, biological products, nutraceuticals, health supplement, traditional medicine and as well as the animal health products to the government hospitals, healthcare centers, clinics, educational institutions and analytical laboratories all over Malaysia and as well as international market.
In RU-Biolife, we constantly strive to provide an excellent healthcare solution to the people by working with globally accredited, reputable and trusted pharmaceutical and medical device manufactures across the global. RU-Biolife are leaded by expertise and management team that has extensive years of experience in healthcare services industry that allows us to emerge as the most reliable and valuable one-stop healthcare solution provider in Malaysia.
Our contribution towards Greener Digital Healthcare
Ultimately adopting to a philosophy - “Digital-Health-First”, RU-Biolife will work in different ways in our bubble to enable the next revolution of Industry 4.0 for medical and healthcare sector in Malaysia. Looking at the perspective of environmental vision, RU-Biolife is responsible and committed on a vital role to establish an environmentally friendly organization and operation. RU-Biolife as the emerging healthcare and life science provider will continuously adhere to the principle of delivering a safety, quality and efficacious products to the people.
Get In Touch!
+603 5121 4800
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