Overview

Jan 1, 2021 - perhaps the most noted date among the life sciences, biotech, and med tech circles. It is obvious because it stands as the transition deadline proposed by the Brexit agreement between the United Kingdom (UK) and the European Union (EU). Though it seems a deadline, continuous updates about Regulatory modifications in the regions are causing manufactures aiming at EU/UK market-entry worried than ever before. Taking the account of current situation, Freyr - with a proven track record in the EU and the UK markets - caters exclusive Brexit-related Regulatory support to life sciences, biotech, and med-tech manufacturers.

For end-to-end compliance in the Brexit scenario, Freyr’s strong Regulatory team provides support to a ll aspects of Regulatory affairs, pharmacovigilance, and compliance. Freyr is working round the clock to ensure all the possible scenarios are mapped and to ensure all the possible outcomes are compliant enough for the successful market-entry. We are prepared for Brexit, so are our clients.

 

Freyr Expertise

Medicinal Products

  • EU/UK Market Analysis
  • Regulatory Consultation
  • Market Access and Regulatory Strategy
  • Regulatory Intelligence
  • Publishing and Submissions
  • Regulatory Labeling
  • Regulatory Artwork Services
  • Regulatory Medical Writing
  • Safety and Pharmacovigilance
  • Audit, Compliance and Validation
  • Regulatory Software and Services
  • Health Authority Interaction

Medical Devices

  • Developing a clear Medical Device Regulation (MDR) implementation strategy
  • End-to-end support to develop Clinical Evaluation Report (CER) including literature search as per European Medical Device Regulation (EU MDR) guidelines
  • In-Country Representation/Legal Representative Services
  • MDR Registration and Submission Assistance to Global Health Authorities
  • Regulatory Intelligence about Importation Process of Various Regulated Markets
  • Person Responsible for Regulatory Compliance Services and Assistance

Food and Food Supplements

  • Help you to keep up to date on the impending Regulatory changes and help you through the transition
  • Regulatory Assistance for Mandatory Amendments to Food/Food Supplement Labels
  • Regulatory Assistance for Import/Export Licenses as per the Changes

Chemicals and Biocides

  • Regulatory Strategic Support for Transitioning
  • OR services in EU-27 for REACH and Biocides
  • Regulatory compliance support for new UK regulations in area of Chemicals (UK REACh), Cosmetics, Biocidal Products (UK-BPR)
  • Supply Chain Regulatory Compliance Review/Assessment
  • Updating Chemical, Biocides Dossiers and Notifications

Technology

  • Software Data Migration Strategies Inclusive of Resource Allocation to Implement and Technological Support
  • Freyr SUBMIT PRO to Support eCTD Publishing and Submissions 
  • Centralized and Collaborative Approach to Data Management and Enhanced Automated Product Lifecycle Management
  • Empowering Robust and Cloud-hosted Software Applications
  • Freyr LABEL 360 to Cater to End-to-End Lifecycle of Labeling
  • Freyr iREADY to Track, Analyse, and Validate Cosmetic Ingredients against New Norms and to Deal with any Brexit Terms
  • Unifying Processes to Single Source of Truth of RIMS (Regulatory Information Management System)

For Comprehensive Information on Brexit & Related Regulatory Assistance,

You Can Also Visit

brexit.freyrsolutions.com