Overview

With an advanced economy and being a healthcare hub in Mediterranean, Malta boasts good scope for foreign medicinal and medical device manufacturers for investments. To obtain the market authorizations, they require approvals from the Malta Medicines Authority (MMA), the agency that regulates the medicinal products and pharmaceutical activities in the region. Though the market seems to be lucrative, lack of regional Maltese Regulatory knowledge might affect manufacturers’ compliance efforts.

Freyr as a specialized global Regulatory partner, assists manufacturers with exclusive Maltese Regulatory affairs to navigate the Regulatory regime for successful and timely deliverables. Freyr’s end-to-end Regulatory services in Malta span across:

  • API
  • Pharmaceutics / Biopharmaceuticals

Freyr Offerings

  • Strategic Regulatory Consulting
  • Strategic business development focusing on the European market
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • End-to-end operational support
  • Dossier preparation, review and management
  • Regulatory Submissions
  • Market assessments
  • In-country representation 

Freyr Advantages

  • 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