Overview

Growing economic conditions and rapidly evolving healthcare systems attract foreign medicinal product and medical device manufacturers to invest in the Portuguese Republic. However, to start with, foreign manufacturers must submit an authorization application to the national medicine regulatory authority (INFARMED), an authority responsible for the monitoring and supervision regulations in the region. Right from requiring an authorized representative from anywhere in the EU region, the language barrier might challenge foreign manufacturer’s effort to enter the region.

Freyr, as an exclusive global Regulatory partner and expert in-country representative, navigates manufactures through respective Regulatory affairs in the region for successful registrations and market authorizations. Freyr is capable to provide Regulatory services in Portugal for:

  • Medical Devices
  • Drugs
  • Biotech

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways
  • Market Authorizations
  • Post-registration / product lifecycle maintenance
  • Life-cycle maintenance (renewals, variations, extensions, ownership transfers)
  • Gap analysis & suggestions of adequacy
  • Dossier Management
  • MRP and DCP submissions in eCTD, CTD and NeeS
  • Evaluation and construction of DMF
  • Quality Systems
  • Production Technical Reports and Quality Control
  • Validation of analytical methodology, Report Assessment
  • Pharmacovigilance
  • PSUR, Safety reports and Safety Studies
  • Regulatory label registrations and evaluation
  • Ingredient review
  • QPPV
  • CE Marking
  • Technical & Strategic Consulting
  • Due Diligence

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with INFARMED
  • Experience and knowledge of European legislation and ICH Guidelines
  • 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