Regulatory & Quality Consulting,
Independent License Holding, Importation, & Distribution

Bring Your Healthcare Products into the
Philippines Market through One Gateway!

  • In-House Local Regulatory Experts
  • Locally & Internationally Certified
  • Strong Network Across Southeast Asian Associations
  • Low Investment
  • More Price Control
  • Easy Termination
  • Freedom to Switch Distributors

Who We Are

We enable you to enter Malaysia’s healthcare market without a local entity or complex license transfers by providing independent license holding, compliant end-to-end logistics, and expert guidance through compliance, certification, and quality assurance processes to ensure your products meet both local and international standards.

Countries We Serve

Our Services

1. Regulatory & Compliance Consulting

Product Registration

  • Product Notification
  • Product Claim Assessment
  • Amendment Submission
  • Assessment Application
  • Product Review & Monitoring
  • Dossier Preparation
  • Product Information Letter Application
  • Certificate of Free Sale Application
  • Product Classification
  • Others
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Regulatory Advice​

  • Product Notification
  • Product Claim Assessment
  • Amendment Submission
  • Assessment Application
  • Product Review & Monitoring
  • Dossier Preparation
  • Product Information Letter Application
  • Certificate of Free Sale Application
  • Product Classification
  • Others
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Due Diligence

  • Product Notification
  • Product Claim Assessment
  • Amendment Submission
  • Assessment Application
  • Product Review & Monitoring
  • Dossier Preparation
  • Product Information Letter Application
  • Certificate of Free Sale Application
  • Product Classification
  • Others
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

2. Quality Assurance Consulting

Halal Consultation

  • QMS Document Creation
  • GMP Clearance
  • SOP Development
  • Risk Assessment
  • Total Quality Management
  • Internal Audit
  • GDPMD Preparation
  • GDPMD Preparation
  • cGMP Preparation
  • DMAIC / Six Sigma Program
  • Kaizen: Continuous Improvement Program
  • Quality & Productivity Improvement Program
  • 8D Problem Solving
  • Failure Effect & Mode Analysis
  • Others
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

QMS Consultation

  • QMS Document Creation
  • GMP Clearance
  • SOP Development
  • Risk Assessment
  • Total Quality Management
  • Internal Audit
  • GDPMD Preparation
  • GDPMD Preparation
  • cGMP Preparation
  • DMAIC / Six Sigma Program
  • Kaizen: Continuous Improvement Program
  • Quality & Productivity Improvement Program
  • 8D Problem Solving
  • Failure Effect & Mode Analysis
  • Others
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

ISO Consultation​

  • QMS Document Creation
  • GMP Clearance
  • SOP Development
  • Risk Assessment
  • Total Quality Management
  • Internal Audit
  • GDPMD Preparation
  • GDPMD Preparation
  • cGMP Preparation
  • DMAIC / Six Sigma Program
  • Kaizen: Continuous Improvement Program
  • Quality & Productivity Improvement Program
  • 8D Problem Solving
  • Failure Effect & Mode Analysis
  • Others
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

3. Independent License Holding & Importation​

Independent License Holder / Marketing Authorization Holder​

  • Low Investment
  • Hassle-Free
  • More Hands-On Control
  • More Price Control
  • Easy Termination
  • Freedom to Switch Distributors
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Importation Assistance​

  • Low Investment
  • Hassle-Free
  • More Hands-On Control
  • More Price Control
  • Easy Termination
  • Freedom to Switch Distributors
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Import Permit

  • Low Investment
  • Hassle-Free
  • More Hands-On Control
  • More Price Control
  • Easy Termination
  • Freedom to Switch Distributors
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Post Market &​ Government Affairs​

  • Low Investment
  • Hassle-Free
  • More Hands-On Control
  • More Price Control
  • Easy Termination
  • Freedom to Switch Distributors
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Local Labelling​

  • Low Investment
  • Hassle-Free
  • More Hands-On Control
  • More Price Control
  • Easy Termination
  • Freedom to Switch Distributors
  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

4. Distribution (B2B Model)​

3PL/4PL Logistics​

  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Transit Warehouse Facility​

  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Inventory & Stock Management​

  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Distributor Screening​

  • Medical Devices
  • Household Health Supplies
  • Cosmetics
  • Health Supplements
  • Food
  • Pharmaceuticals
  • Quasi Drugs
  • Household Urban Pesticides
  • Others

*Subject to Consultation

Our Teams, Facilities & Certifications

Our In-House Regulatory Expert

(Malaysia Native)

Uma Devi Sadasivam

Regional Director of Operations

  • More than 30 Years of Experience in Quality Assurance
    & Regulatory Affairs Field in a Global Healthcare Company​

Fadhlullah Ilman

Malaysia Regulatory & QualityAffairs Officer

  • More than 5 Years of Experience in Regulatory Affairs
  • Knowledgeable in Regulation for Medical Devices,
    Cosmetics, Traditional Medicine, Health Supplements,
    Food and Household Product
  • Experienced in Quality Control and Logistics

Our Certifications & Active Membership in Healthcare Associations

Our Facilities

Malaysia Office

Local real office with dedicated local representative supporting regulatory and commercial activities.​

Transit Warehouse

A compliant transit warehouse supporting secure handling and temporary storage of products.​

Our Clients in Malaysia