Steadily growing economy along with the increasing demand for quality medicinal products and medical devices in Malaysia attracts foreign manufactures across the globe to invest in the region. To do so, manufacturers must get the market authorizations from the Ministry of Health. While the Drug Control Authority (DCA) oversees the pharmaceutical registrations in the region, the Malaysian Medical Devices Authority (MDA) regulates medical device registrations. Considering the rapid market expansion and radical regulatory transformations, Malaysian market access for foreign manufacturers would be anything but complicated and time consuming.  

With an updated Regulatory intelligence over the new Regulatory system of Malaysia, Freyr assists new market entrants to keep pace with the improved Regulatory requirements related to registrations, dossier compilation, submissions for necessary market authorizations. Freyr’s end-to-end Regulatory services across Malaysia span across:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory Affairs & Regulatory intelligence
  • Dossier management
  • Regulatory Submissions
  • New chemical entities
  • Pharmacovigilance

Freyr Advantages

  • Strategic local health authority contacts – with Ministry of Health, Malaysia
  • Expert Regulatory team with proven global RA expertise
  • Proactive and Collaborative approach
  • Quick turnarounds and faster time-to-market
  • Keeping abreast with region-specific legislation and Regulatory guidelines