Navigating
Regulations Together
Experience and
Expertise in
Every Step
We're a close-knit team of regulatory affairs consultants with roots in pharmaceuticals, medical devices, and healthcare.
With decades of extensive combined experiences in regulatory work across Malaysia, Singapore, and the ASEAN region, we bring a wealth of knowledge to your projects.
Our mission is to support your business objectives by developing and delivering regulatory strategies that work for you.
Our Promises
Tailored
Regulatory Strategy
We focus on understanding evolving requirements and translating them into customised regulatory solution for your business needs.
Dedicated Regulatory
Affairs Team
Our clients receive exclusive attention with our regulatory focus team.
Precise and
efficient processes
We make regulations simple by using precise strategies and a smooth workflow.
Committed
Partnership
We listen, understand, and journey together with you through your regulatory projects.
Our commitment extends from advisory services during pre-registration to post-registration support.
As a modest-sized team, you can communicate with us directly without multiple layers.
We're dedicated to finding alternatives for handling challenges and projects.
What our clients are
saying about us
Reliable Trust and Professional Guidance
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The word to describe SKRA's service and business relationship is 'Trust.' I can simply count on SKRA to complete the task without further hesitation. It's basically peace of mind as SKRA knows well what needs to be done. SKRA's professional advice helps me to have a better understanding of the market too.
Experienced Team for Smooth Projects
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SKRA has a team of experienced consultants with a breadth of knowledge in regulatory affairs. With their support, regulatory affairs projects of the company run smoothly. We highly recommend SKRA if any individual or company needs professional consultant service in regulatory affairs.
Combination Product Expertise
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Not many consultants have knowledge in combination products (Device-Drug / Drug Device) submissions. Happy to have a good consultant to handle it.
Going the Extra Mile with High Engagement
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We're delighted with SKRA's advisory role. They proactively conducted online research even before our first meeting, greatly aiding our regulatory affairs (RA) strategy. SKRA attentively addressed our concerns about technical limitations and bottlenecks. They also joined us for a productive discussion with health authorities. Post-meeting, SKRA showed high engagement by preparing proposal for our next steps.
Thorough Analysis, Timely Delivery
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In conclusion, SKRA has provided attentive and precise analysis using existing resources in the compilation of the documents and managing correspondence. Besides, all activities were completed within the stipulated timeline, and we look forward to collaborating with SKRA in the future.
Regional Strategy Advantage
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SKRA's regional knowledge provides a better strategy for concurrent submissions in other countries.
Prompt Service for Confident Progress
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SKRA's service to us has been prompt and friendly. Their connection with health authority is of great benefit in obtaining precise and prompt information for us to move forward with confidence.
Highly Satisfied Client
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I am happy to engage SKRA in registering my products, they are responsive and effective. SKRA has great knowledge in handling the queries from health authorities. They often advise me on how to prepare my document to fulfil the regulatory requirements. In overall, I am very satisfied with their performance.
Exceptional Strategy and Advice
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Very good strategy and advice especially dealing with products that fall under borderline. SKRA is relentless to provide proposals and solutions.