Overview

Due to its central location in Asia, Singapore offers potential growth opportunities for Medical Devices, Pharmaceuticals, Cosmetics and Food Supplements manufacturers across the globe. The Health Sciences Authority (HSA) under the purview of Ministry of Health (MOH) regulates all the procedures. Though the Regulatory system in the region believed to be industry-friendly, it’s constantly evolving regulatory frameworks and registration & licensing procedures might pose a great challenge for manufacturers to keep pace with the standards.

Freyr, as a global Regulatory partner can assist you prepare necessary Regulatory documents and submit your applications to the Singaporean regulatory authorities. Freyr’s regulatory affairs (RA) experts will navigate you through the regulatory system of Singapore to obtain product registrations and approvals in short timeframes and the most cost-effective way possible. Freyr’s Regulatory Affairs services for Singapore span across:

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory affairs & Regulatory intelligence
  • Medical writing
  • product classification: food, health supplement, functional food, TCM, OTC/drug
  • NCE/NDA registration dossier compilation
  • Product license maintenance
  • Regulatory CMC strategy
  • Drug Master File (DMF) compilation for open and closed parts
  • Authorized representation
  • Regulatory Intelligence reports.

Freyr Advantages

  • Strategic local health authority contacts - with HSA
  • Proven case of 250 + Submissions
  • 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