Overview

The increasing demands for quality healthcare and the rapidly emerging economic sector presents Vietnam as a beneficial market for foreign Drug or Device manufacturers. All medicinal products to be imported into the region requires approval from the Ministry of Health (MOH) and the Drug Administration of Vietnam (DAV) while medical devices are regulated by the Department of Medical Equipment and Health Works (DMEHW). Communicating with different internal regulatory bodies might pose a challenge for foreign manufacturers who are new to Vietnamese Regulatory system.

Freyr, as a global regulatory partner, assists foreign manufacturers in interpreting the Vietnamese regulations and advises them on Regulatory strategies to be implemented for the region for compliant market authorizations. With streamlined and quicker submission procedures, Freyr provides Regulatory consulting services in Vietnam for:

  • Pharmaceuticals
  • Medical Devices
  • Cosmetics
  • Food and Dietary Supplements
  • Bio-Tech

Freyr Offerings

  • Strategic Regulatory affairs consulting
  • Regulatory intelligence
  • Registration pathways and license management services
  • Dossier preparation, review and management
  • Regulatory Labelling
  • Obtaining approvals for labeling, advertising

 

Freyr Advantages

  • Strategic local Health Authority contacts - with DAV and VFA
  • Expert Regulatory team with proven expertise and experience
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislations and Regulatory guidelines