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Regulatory
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Cosmetics are product defined as “any substance or preparation intended...
Cosmetics
Generic Product Registration: Generic Product is defined by NPRA as...
Generic
Health Supplement Registration: Health Supplement product is defined by NPRA...
Health Supplements
Herbal product is defined by NPRA as any product used...
Herbal
Biologic product is defined by NPRA as product whose active...
Biologic/ Biosimilar
New Drug Product is defined by NPRA as any pharmaceutical...
New Drug Product Hybrid
Marketing Authorization/Product Registration Holder Services We also offers services as MA/PRH...
Additional Services
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Evolving Landscape of Non-Clinical Study in Regulatory Approval Process
Late last year, a significant law was passed by the United States (US) called as “FDA Modernization Act...
Complex Generic Product Registration
The boundaries of a generic product registration are expanding at a greater rate yearly. It has evolved far...
Biologics & Biosimilars, are they an equivalent to the originator product ?
This is a question still lingering in the pharmaceutical industry for some time. Biologics/biosimilars are not like the...
Registration Process Scenario in Malaysia
Registration of pharmaceutical products in Malaysia is not as straight forward process as compared to other ASEAN countries....
Classification of Products
In Malaysia, there are several classes of pharmaceutical registration regulated by NPRA. These would include New Chemical Entity,...