Regulatory Affairs
Regulatory Affairs
Our dedicated and experienced Regulatory Affairs team is able to navigate the regulatory processes and help medical, pharmaceutical and life science companies successfully registering their products in Malaysia.
Regulatory Services
Our Regulatory Department will assist Principal in the area of registration of product.
- Update Principal regarding any changes in the Product Regulatory requirement.
- Assist Principals to answer to enquiries that is requested by the Drug Control Authority regarding adverse drug reactions or other issues pertinent to the product.
Medispec holds Import License, Wholesaler's License, Type A Poison License and Establishment License for Authorized Representative
Registered Medicines (including Health Supplements)
- Manufacturer's License
- Poison License
- Import License
- Wholesaler's License
Registered Medical Devices
- Establishment License for Manufacturer
- Establishment License for Authorized Representative
- Establishment License for Distributor
- Establishment License for Importer
Any party seeking to manufacture, sell, supply, import, possess or administer any medicinal products must:
- Register the product
- Holds the appropriate license required
Each license is valid for one year.
Categories of Medicinal Product:
- New Drug Products
- Biologics
- Generics
- Health Supplements
- Natural Products
- Veterinary Products
Regulatory Services
- We provide registration and regulatory consulting services for pharmaceutical products, health supplements, cosmetics and medical devices.
- Our regulatory affairs experts maintain ongoing liaisons with regulatory authorities, manage our clients’ dossiers, process a large number of marketing authorizations on behalf of our clients and safeguard their interests.
Step 1
Pre-registration
Regulatory Feasibility Assessment & Product Classification
Step 2
Registration
Dossier Compliance Check, Dossier Submission & Registration Follow Up
Step 3
Post-Marketing
Market Authorization (MA) Maintenance, Product License Renewal & Product Variation (Minor / Major) Filing
Let’s Team Up on Your Next Project
Drop us a line, we’d like to hear from you!