Who We Are

Strategic Regulatory Partners

Bridging the gap between global healthcare innovation and Malaysian market access.

About ARCI

ARCI Regulatory Consultancy provides expert regulatory strategy, dossier compilation, and submission management, helping pharmaceutical and medical device companies navigate Ministry of Health (MOH) Malaysia requirements with a 98% approval success rate.

More Than Just Paperwork.
We Are Your Strategic Asset.

ARCI Regulatory Consultancy was founded to solve a critical problem in the Malaysian healthcare market: the complexity of regulatory compliance. What started as a small advisory firm has grown into a premier consultancy trusted by multinational pharmaceutical giants and innovative biotech startups alike.

Our Mission

To accelerate the availability of safe, quality healthcare products in Malaysia by providing scientifically sound and ethically robust regulatory pathways.

ARCI Team Meeting
98% Approval Success Rate
15+
Years of Experience
500+
Projects Completed
30+
Therapeutic Areas

The ARCI Advantage

Regulatory affairs is not just about filling forms. It’s about strategy, foresight, and relationships.

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Speed to Market

We use our deep understanding of NPRA workflows to prevent common dossier errors that cause months of delay. We get it right the first time.

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Agency Relationships

We maintain professional, transparent relationships with officers at MOH, NPRA, and MDA, allowing for clear communication on complex files.

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Scientific Expertise

Our team includes pharmacists and scientists who understand the molecular and clinical data, not just the regulations.

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Lifecycle Management

We don't just register and leave. We manage variations, renewals, and post-market safety reporting for the life of your product.

Deep Expertise in Local Frameworks

We specialized in the specific requirements of Malaysia's key regulatory bodies.

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NPRA (National Pharmaceutical Regulatory Agency)
Drugs, Biologics, traditional medicines, and cosmetics.
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MDA (Medical Device Authority)
Medical devices, IVDs, and establishment licenses.
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FSQD (Food Safety & Quality Division)
Functional foods, health drinks, and labeling.
Ministry of Health Malaysia

Ready to Enter the Market?

Don't let regulatory hurdles slow you down. Partner with ARCI for a smooth, compliant journey.

Speak to a Consultant

About Us FAQs

ARCI is a specialized regulatory consultancy based in Malaysia, helping businesses obtain product approvals from the National Pharmaceutical Regulatory Agency (NPRA) and Medical Device Authority (MDA).
We serve the pharmaceutical, cosmetic, medical device, health supplement, and functional food industries, providing compliance solutions for manufacturers and distributors.
No, ARCI is an independent private consultancy. We act as a professional liaison between your company and regulatory authorities like the MOH, NPRA, and MDA.
Our team consists of pharmacists, scientists, and regulatory experts with over 15 years of combined market experience in Malaysian regulatory affairs.