Overview

With an extremely diverse business opportunities, Taiwan boasts a beneficial investment scenario for foreign medicine and medical device manufacturers. Taiwan Food and Drug Administration (TFDA) under the guidance of Department of Health (DOH) oversees the regulatory activities in the region. Though the region seems to be lucrative, constantly evolving Regulatory landscape might challenge the manufacturers with region-specific Regulatory obligations.

Freyr as an exclusive global Regulatory partner understands the Taiwan Regulatory environment and assists manufacturers to impeccably carry out compliant Regulatory procedures for successful market authorizations and registrations. Freyr’s Regulatory services in Taiwan span across:

Freyr Offerings

  • Strategic Regulatory consulting
  • Regulatory Consulting
  • Regulatory Submission: NDA, ANDA, PMF, DMF submissions
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services

Freyr Advantages

  • Strategic local Health Authority contacts – with TFDA
  • 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