FAQs
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Frequently Asked Questions
Get quick answers to frequently asked questions about our services.
How long does the product registration process take?
The duration varies depending on the type of product and regulatory authority. Typically:
- Pharmaceutical products: 210 t0 245 working days
- Health supplements & traditional products: 116 to 136 working days
- Medical devices: 6-12 months
- Cosmetics: 1-3 months
- Food products: 3-6 months
What documents are required for product registration?
The required documents vary, but generally include:
- Product formulation details
- Manufacturing licenses and GMP certificates
- Stability studies and safety data
- Labeling and packaging information
- Clinical and technical dossiers (if applicable)
Can Victory Pharma Consultancy assist with market sampling applications?
Yes, we provide support for market sampling applications, including Notification Exemptions for cosmetic products and other regulatory testing approvals.
What are the costs involved in product registration?
Costs depend on the regulatory fees, dossier preparation, and additional testing requirements. We offer consultation to provide a cost estimate based on your specific product needs.
Does my company need a local representative to register products in Malaysia?
Yes, foreign companies must appoint a local authorized representative to handle the registration process with NPRA, MDA, or FSQD.
What happens if my product is rejected by the regulatory authority?
If a product is rejected, we can assist in identifying the reasons and preparing additional data or modifications for resubmission. Our regulatory experts ensure compliance to minimize risks of rejection.
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