Overview

In order to gain access to the Czech Republic, foreign manufacturers are obliged to get authorizations from the State Institute for Drug Control (SUKL). Apart from obtaining must-to-have CE marking for medical devices, manufacturers need an authorized representative for obtaining registrations and gain market approvals. To do so, the challenge lies with procedural complexities that a foreign manufacturer may find difficult to handle.

Freyr, as a specialist global Regulatory partner, assists foreign manufacturers in decoding the local regulatory requirements and comprehensive product classification based on relevant SUKL Regulations. In addition, Freyr assists foreign manufacturers with mandatory Regulatory submissions for streamlined registrations and approvals. Freyr's end-to-end Regulatory Affairs consulting for Czech Republic span across:

  • Medical Devices
  • Pharmaceuticals / Drugs
  • Cosmetics and Food & Dietary Supplements
  • OTC
  • Biologics

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
  • Regulatory Submissions
  • Dossier preparation, review and management
  • Preparation and validation of the NeeS and eCTD sequence
  • Documentation support for variations and renewal submissions for all EU countries
  • Cooperating with CMC department in preparation of Module 3 documents
  • Cooperating with API manufacturers in preparation of CEP certificates
  • Batch analyses and other documentation for Module 3
  • SmPC, PIL, Labeling
  • Pharmacovigilance
  • Market assessments
  • In-country representation

Freyr Advantages

  • Strategic and well-versed local regulatory knowledgebase – with MOH
  • 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