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We specialise in regulatory compliance within the Life Sciences industry, in particular, the medical devices sector. Our services are focused primarily on the regulatory aspects of your business. We can help you achieve regulatory compliance by implementing and maintaining the required quality standards – Good Distribution Practice for Medical Devices (GDPMD) for importers and distributors, ISO 13485 for medical device manufacturers and registering your products with the Medical Device Authority (MDA) so they can be brought to market promptly and efficiently.
Our dedicated team of qualified and experienced consultants specialises in regulatory compliance, quality management systems and market access for the medical device industry.
Formed in 2004 as CubicPharma Pte Ltd in Singapore to provide engineering, commissioning and validation services to global pharmaceutical companies setting up manufacturing facilities in Asia, we expanded our services to include medical devices when the Health Sciences Authority of Singapore (HSA) introduced the Health Product (Medical Devices) Regulations in 2010. Three years later, in 2013, we established Cubic Life Sciences Sdn Bhd in Malaysia after the Malaysian Medical Device Act, Act 737, was introduced.
Free yourself from having to worry about regulatory compliance. Our regulatory specialists will provide comprehensive support for your business – sharing our knowledge and experiences to help you succeed with your compliance objectives. Benefit from our know how, acquired and honed over the years.
All our services are designed to make your life easier and allow you to focus on what you do best – running your business – whilst we undertake the compliance aspects for you. We offer a premium service at a competitive price. Let us work as part of your business and your regulatory team and assist you with navigating complex regulations, ensuring compliance, and accelerating market success.
Professional Guidance
Customised QMS
Regulatory Advice
Exceptional Service
We understand the challenges of designing and implementing quality management systems. We understand the challenges of preparing technical documentation for submission to the regulatory authorities. Our consultants are committed individuals, academically and professionally qualified, with the breadth and depth of experience gained from years working with a worldwide client base over hundreds of projects. Together we form a team to support you and your business with a responsiveness that is hard to match.
Sentral Business Suites @ Komplek Sentral Point, Taman Kajang Sentral, Kajang 43000, Selangor, Malaysia.
+60 3-8740 8318 , +60 3-8741 7681
©2023 Cubic Life Sciences Group. All Rights Reserved.
©2024 Cubic Life Sciences Group. All Rights Reserved.
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