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Services

Pharmacovigilance

Vigilance for Medical Devices

OUR SERVICES PROVIDE COMPLIANCE WITH MDR, IVDR AND ISO 13485-2016:

  • Compliance with guidelines and legislation
  • Person responsible for regulatory compliance (PRRC)
  • Establishing a quality system and training of personnel
  • Post-market surveillance system
  • Assessment of incidents and events
  • Reporting of incidents and other events
  • Preparation and reporting of Field Safety Corrective Action (FSCA)
  • Preparation of Field safety notice (FSN)
  • Preparation of Periodic safety update reports
  • Setting up appropriate contractual arrangements and supervision
  • Audits and pre-inspection consultations

How to Reach us?

Billev farmacija vzhod, d. o. o.
Billev Pharma East Ltd.
Tržaška cesta 202

1000 Ljubljana

Slovenia

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billeveast@billeveast.com

+386 123 22095

Tržaška cesta 202
1000 Ljubljana
Slovenia

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