Regulatory and Quality Consultants

Malaysia

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.

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Years Of Experience

Continents

MDA Consultant

Project Manager

Analyst

Human Resources

Consulting Service for Medical Device in Malaysia

Searching for a Professional Medical Device Consultant?

Our dedicated team of qualified and experienced consultants specialises in regulatory compliance, quality management systems and market access for the medical device industry.

About Us

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.

How We Can Help You

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.

What we provide

Our Services

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

Why Choose Us

We Listen, We Deliver

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.