Trusted Compliance Partner

Expert Regulatory
Compliance for
Malaysia

Navigate MOH (KKM), NPRA, and MDA frameworks with precision and speed. We provide tailored enterprise solutions for seamless market access.

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About ARCI Regulatory Consultancy

ARCI is Malaysia's premier regulatory consultancy, specializing in National Pharmaceutical Regulatory Agency (NPRA) drug registration, cosmetic notification, and Medical Device Authority (MDA) compliance. We provide end-to-end market access solutions for local and international healthcare enterprises seeking approval from the Ministry of Health (MOH/KKM) Malaysia.

Navigating Malaysia's
Regulatory Landscape

ARCI provides specialized regulatory, compliance, and insight solutions for businesses seeking product approvals in Malaysia. Our deep expertise in NPRA, FSQD, MDA, and GDPMD frameworks ensures your path to market is clear, compliant, and efficient.

✔ Direct communication with regulatory bodies
✔ Comprehensive dossier preparation
✔ End-to-end license management
Navigating Malaysia's regulatory landscape

15+

Years of Market Experience

Our Core Regulatory Services

Comprehensive registration and compliance solutions tailored for every product category in the Malaysian market.

New Drug Registration

New Drug Registration

Strategic guidance for NCEs and biologicals ensuring full NPRA compliance and successful market entry.

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Cosmetic Notification

Cosmetic Notification

Efficient notification services for cosmetic products via the Quest3+ system with rapid processing.

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Generic Product Registration

Generic Product Registration

Streamlined approval pathways for scheduled poisons and OTC generics with comprehensive support.

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Health Supplements

Health Supplements

Ensuring safety and quality compliance for health and dietary supplements in the Malaysian market.

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Medical Device Registration

Medical Device Registration

Full lifecycle support for MDA registration and GDPMD compliance for all device classifications.

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Food & Nutrition

Food & Nutrition Products

Classification and compliance advisory for Food-Drug Interphase (FDI) products and health food labels.

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Frequently Asked Questions

The NPRA is the regulatory authority under the Ministry of Health Malaysia responsible for ensuring that pharmaceuticals, cosmetics, health supplements, and related products marketed in Malaysia are safe, of good quality, and compliant with regulatory requirements.
While NPRA acts as the regulator and enforcement authority, ARCI supports businesses in navigating regulatory requirements efficiently and compliantly by advising on pathways, reviewing formulations, and managing submissions.
Timelines vary significantly by product type (e.g., 2-3 years for New Drug Products vs. shorter timelines for Cosmetics). We provide realistic timelines based on current Ministry of Health (MOH) performance data.
Yes, foreign companies typically require a local Product Registration Holder (PRH) to register products with the MOH. ARCI can advise on the requirements for PRH appointment.
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