New registration with NPRA (National Pharmaceutical Regulatory Agency), including new chemical entity, biologics, biotech, vaccines, OTCs, cosmetic, traditional preparation and medical devices.
Gap Analysis, Dossier Reviews and Product Classification based on active ingredients and mode of delivery
New medical device registration with MDA (Medical Device Authority), including establishment of license and device class registration.
Managing regulatory affairs of current active dossiers on behalf of clients including managing QUEST3+ and growing product variations and licenses.
Establishing and managing Import License on behalf of clients
We provide local representation for international clients entering the Malaysian market, serving as their Marketing Authorization Holder (MAH).
Establish and manage Halal certification by JAKIM for products and establishments including streamlining the required documents and processes for establishments.
We are licensed & certified to supply medical devices & pharmaceutical supplies to any government agencies and medical facilities.
Products include prescription drugs, Healthcare supplements, Food supplements, Over the counter products, Medical equipment and devices, also Disposable medical items.
Authorized supplier of pharmaceutical and medical products to Malaysian government agencies.
Licensed to hold and distribute scheduled and controlled drug products.
Approved to wholesale pharmaceutical and medical products across Malaysia.
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We provide a range of services for new product development, including market studies and analyses. Our expertise extends to consulting on marketing plans tailored to your regional directions, including proposing market launch strategies and post launch analysis.
