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Regulatory Affairs

Services

  • Regulatory Affairs
  • Pharmacovigilance
  • Market access
  • Services
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  • Regulatory Affairs
  • MA maintenance procedures
  • Regulatory submissions (National applications, Classification, Variations, Parallel Import, MA transfers, Compassionate use)
  • Notifications for Medical Devices and Food Supplements
  • Local Support in MRP and DCP
  • Review and updates/approvals of product information
  • Approval and review of promotional materials
  • Acting as MA Applicant in National Procedure
  • Harmonization of regulatory documents/submissions on Baltic level
  • Clinical Trial Applications
  • Regulatory review and consulting - regulatory documentation compliance review
  • Negotiations and consultations with National Authorities
  • Strategic analysis and consultancy for selection of the optimal regulatory strategy
  • Regular updates on national regulatory legislation changes





    • About
    • Services
      • Regulatory Affairs
      • Pharmacovigilance
      • Market access
    • News
    • Contact us