Regulatory & Quality Consulting,
Independent License Holding, Importation, & Distribution
Dalhin ang Iyong mga Produktong Pangkalusugan sa
Malaysia 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
Sino Kami
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.
Mga Bansang Aming Pinaglilingkuran
Aming mga Serbisyo
Product Registration
Regulatory Advice
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
Halal Consultation
QMS 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
Independent License Holder / Marketing Authorization Holder
Importation Assistance
Local Labelling
Import Permit
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
3PL/4PL Logistics
Transit Warehouse Facility
Inventory & Stock Management
Distributor Screening
- Medical Devices
- Household Health Supplies
- Cosmetics
- Health Supplements
- Food
- Pharmaceuticals
- Quasi Drugs
- Household Urban Pesticides
- Others
*Subject to Consultation
Ang Aming mga Koponan, Pasilidad at Sertipikasyon
Ang Aming Eksperto sa Regulasyon sa Loob ng Kompanya
(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
Ang Aming mga Sertipikasyon at Aktibong Pagiging Miyembro sa mga Asosasyon ng Pangangalagang Pangkalusugan
Ang Aming mga Pasilidad
Malaysia Office
Tunay na lokal na opisina na may nakalaang lokal na kinatawan na sumusuporta sa mga gawaing pangregulasyon at komersyal.
Our Address
E-03-05 Gamuda Biz Suites, Persiaran Anggerik Vanilla 31/99, Seksyen 31, Kota Kemuning, Shah Alam, 40460 – Malaysia
Transit Warehouse
A compliant transit warehouse supporting secure handling and temporary storage of products.
Our Clients in Malaysia
