Greetings from Freyr Malaysia
Freyr is one of the largest global, Regulatory-focused solutions and services companies. We support Life Sciences companies entering Malaysian pharma market in their entire Regulatory value chain, ranging from Regulatory strategy, market intelligence, local representation, and post-approval product maintenance functions.
The National Pharmaceutical Regulatory Agency (NPRA) is the national Regulatory body of Malaysia. Health supplements and cosmetic products are regulated directly by the NPRA. The Drug Control Authority (DCA) regulates the medicinal products, whereas the Medical Device Authority (MDA) regulates the medical devices’ registration in Malaysia.
With our on-ground team of Malaysian Regulatory experts, we support you in obtaining approvals from the NPRA, DCA, and MDA and ensure a smooth market entry of your products in Malaysia.
Industries We Serve
Medicinal products in Malaysia are regulated by the Drug Control Authority (DCA). The DCA was formed under the Drugs and Cosmetics Regulations (CDCR) 1984 from the Sale of Drugs Act 1952. DCA is the stake holder for quality control activities, licensing and post-registration activities. The National Pharmaceutical Regulatory Agency (NPRA) carries out scientific and technical reviews, inspections and surveillance activities of the medicines.
- End-to-end Registration Support
- Authorized Local Agent Support
- Manufacturing Site Approval Support
- Import Registration Support.
- Regulatory Affairs Consulting
Malaysian Medical Device Authority (MDA) is the Agency that controls and regulates the medical device registration. MDA was established under the Medical Authority Act 737, 2012. MDA uses a centralized online application system called MedCast for submissions related to Medical Devices. The Conformity Assessment Body (CAB) carries out the technical data evaluation under the authorization of the MDA.
- Authorized Local Representation
- End-to-end Medical Device Registration with the MDA
- Regulatory Intelligence & Solutions
- Preclinical Services - Generation of Scientific Report for Regulatory Submissions
- MDA Establishment License Application
In Malaysia, health/food supplements with general and functional claims are regulated under the category of medicinal products requiring registration and approval from the National Pharmaceutical Regulatory Agency (NPRA). A Health supplement is a product used to supplement a diet and to maintain, enhance and improve the health function of the human body.
- Food Product Classification
- Formula Review/Ingredients Assessment
- Food Label and Claims Review
- Compliance as per New labeling Regulation
- Claims Consultation and Substantiation
Current import trends depict a growing curve for cosmetic products in Malaysia. All cosmetic products, which are intended to be marketed and distributed in the local market are required to be notified with the National Pharmaceutical Regulatory Agency (NPRA) Malaysia, formerly known as the National Pharmaceutical Control Bureau (NPCB).
- Product Classification
- Cosmetics Notification Holding
- Formulation/Ingredient Analysis
- Claims Review
- Label Review
- Cosmetic Notification in Malaysia with the NPRA
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Freyr SPAR is one such RIM Solution that enables Life Science organizations to effectively manage the information right from tracking product registrations to generate statistical reports.
Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.Know More
Our Regional Expertise
Being a Globally Local firm, we have our presence in the following countries, click to know more