Overview

Growing consumer demand for moderate availability of new healthcare technology makes United Kingdom (UK), a lucrative market for pharmaceuticals, medical devices and biotech manufacturers. Medicines and Health products Regulatory Agency (MHRA) oversees / regulates respective Regulatory activities in the region. With different types of procedures to be chosen (Centralised Procedure [CP], National Procedure [NP], Decentralised Procedure [DCP] and Mutual Recognition Procedure [MRP]), the Regulatory regime in the UK might stand a challenging aspect to deal with to obtain necessary market authorizations.

Freyr with an exclusive operational center in UK, assists foreign manufacturers with localized Regulatory Affairs and operational support for required Regulatory procedures. Freyr’s end-to-end Regulatory affairs consulting for UK region span across:

  • Pharmaceuticals products
  • Medical Devices
  • Biologics
  • Cosmetics
  • Food and Dietary Supplements
  • OTC

Freyr Offerings

  • Strategic Regulatory Consulting
  • Regulatory roadmap for market access
  • Regulatory Affairs & Regulatory intelligence
  • Registration pathways and license management services
  • Market Authorizations (MAA)
  • End-to-end operational support
  • Regulatory submission guidance and preparation
  • 510(k) Submissions
  • Dossier preparation, review and management
  • GLP, GCP
  • Pharmacovigilance
  • Safety Reports
  • CE marking
  • Patient Information Leaflet (PIL) and Summary of Product Characteristics services
  • Regulatory Labelling
  • In-country representation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with UK MHRA
  • 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