Overview

With steadily growing healthcare market, Indonesia offers excellent business opportunities for foreign medicinal products and medical device manufacturers. Under the authority of Indonesian Ministry of Health (MOH), the Indonesian National Agency of Drug and Food Control (Badan Pengawas Obat dan Makanan - BPOM) oversees the regulations for medicines and medical devices in the region. To get the market access, manufacturers must navigate through the complex regulatory procedures that range from regulatory requirements, registration procedures and market authorizations.

Freyr, as a global Regulatory partner, can assist manufacturers to navigate through the complex regulatory procedures that range from dossier compilation, regulatory submissions for obtaining market approvals in time. Freyr’s is capable to provide registration and approval assistance for:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Dossier management
  • Regulatory Submissions
  • Good Manufacturing Practice
  • Regulatory roadmap for market access

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with BPOM
  • 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