XLE Business are doing consultants on pharmaceuticals

Through this network, we can offer our clients top level and most-up-to-date drug regulatory information consulting services, in compliance with WHO and PIC/s Standard under National Pharmaceutical Control Bureau (NPCB/NPRA), Ministry of Health Malaysia (KKM).

OUR SERVICE

1.MSC TRUSTGATE TOKEN APPLICATION

We assist you to register membership and company particulars online and purchase a MSC Trustgate USB Token that will enable you to access your Quest account online for product registration.

2.PRODUCT CLASSIFICATION (FOOD/DRUG)

This application important to help manufacturer, importer and distributor to determine the category of a product that falls within the food-drug interphase (FDI) whether the products are regulated as drug (health supplement or natural product under the NPRA’s purview) or, as food (under the FSQ’s purview) because different regulatory requirements apply.

3.HEALTH SUPPLEMENT APPLICATION MAL

We offer advisory, consultancy for manufacturer, importer and distributor to register health supplement product in Malaysia to have MAL approval with National Pharmaceutical Regulatory Agency (NPRA).

Any product that is used to supplement a diet and to maintain, enhance and improve the health function of human body.

4.NATURAL PRODUCT APPLICATION (TRADITIONAL HERBS) MAL

We offer advisory, consultancy for manufacturer, importer and distributor to register Traditional Medicine, Finished Herbal Product, Herbal Remedy and Homeopathic Medicine to have MAL approval  in Malaysia with National Pharmaceutical Regulatory Agency (NPRA).

5.COSMETIC APPLICATION(NOT)

We assist and offer advisory for cosmetic manufacturer , importer and distributor to register their cosmetic product to have NOT approval in Malaysia before placing product in market.

6.FOOD LABELLING APPLICATION

All pre-packed food requires a food labelling that display certain mandatory information. All foods will be subject to general food labelling requirements and any labelling provided must be accurate and not misleading.

7.COMPLIANCE & LICENSING – GMP MANUFACTURER / IMPORT / WHOLESALE / FREE SALES / KKLIU

Any company that want to manufacture, import or wholesale any registered products need to have Manufacturer’s License, Import License or Wholesale License. Licensing unit, Centre for Compliance and Licensing (CCL) involves in the activity of issuance of License.

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