Services

Comprehensive Regulatory Solutions

End-to-end compliance services tailored for the Malaysian healthcare and consumer goods market.

Our Regulatory Services

ARCI offers comprehensive regulatory services for New Drug Registration, Cosmetic Notification, Medical Device Registration (Class A-D), and Food Safety compliance. We guide you through the entire lifecycle from classification to post-market maintenance in full compliance with MOH Malaysia standards.

Our Expertise Categories

We cover the entire spectrum of regulated products under the Ministry of Health Malaysia.

New Drug Registration

New Drug Product Registration

Full dossier preparation for New Chemical Entities (NCE), Biologics, and innovator products. We handle preclinical and clinical data submission to NPRA.

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Generic Product Registration

Generic Product Registration

Cost-effective registration strategies for generics. We assist with Bioequivalence (BE) study protocols and comparative dissolution profiles.

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Cosmetic Notification

Cosmetic Notification

Rapid notification via the Quest3+ system. We ensure your Product Information File (PIF) is audit-ready and compliant with ASEAN Cosmetic Directives.

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Health Supplement Registration

Health Supplement Registration

Guidance on active ingredient limits, permitted claims, and safety data requirements for vitamins, minerals, and functional supplements.

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Traditional Product Registration

Traditional Product Registration

registration services for herbal medicines, Traditional Chinese Medicine (TCM), and Ayurveda products, including quality control testing advice.

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Medical Device Registration

Medical Device Registration

End-to-end support for Class A, B, C, and D medical devices. Assistance with GDPMD certification and CAB conformity assessments.

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Food & Nutritional Products

Food & Nutritional Products

Advisory on Food-Drug Interphase (FDI) classification. We help ensure your food labels and nutritional facts meet FSQD standards.

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Our Engagement Process

A systematic approach to ensuring your regulatory success.

1

Feasibility Analysis

We review your product's formulation and claims to determine the correct classification and likely approval probability.

2

Dossier Compilation

Our team compiles the full technical dossier (administrative, quality, non-clinical, clinical) according to ACTD or CSDT standards.

3

Submission & Monitoring

We submit the application via Quest3+ or MeDC@St and actively monitor its status, responding to any QUEST queries.

4

Approval & Maintenance

Upon approval, we hand over the registration certificate or act as your license holder for post-market maintenance.

Why Classification Matters?

Incorrect product classification is the #1 reason for registration delays. A product might look like a cosmetic but be classified as a drug due to a single active ingredient.

Our gap analysis prevents these costly mistakes before you even start.

Request a Gap Analysis

General Service FAQs

Product classification depends on the active ingredients and claims. Health Supplements and Traditional Medicines are registered with NPRA, while some functional foods fall under FSQD. We start with a classification check.
Yes, we act as the local authorized representative for overseas manufacturers, bridging the communication gap with Malaysian authorities.
Timelines vary: 1-3 years for New Drugs, 12-18 months for Generics/Supplements, and 1-3 months for Cosmetic Notification.
Yes, we provide ongoing support for adverse event reporting, product recalls, and license renewals to ensure continued compliance.