Wholesale distribution authorisations

Medicinal products- regulatory procedures for obtaining distribution authorization and management of already issued licenses

Medical devices – management of procedures for Medical devices wholesale distribution authorisation

Food supplements- regulatory procedure for obtaining of authorisations and inclusion in the list of approved operators with food supplements

Changes in wholesale distribution auhorisations – support and management in any license amendments

Audit services

Audit for assessment of compliance to GDP,  GVP and GMP requirements

Pre-inspection gap analysis audits – identifying the deviations and management of corrective and preventive actions

Preparation for Health authority inspections and audits of Partners

Quality Expert Services

Quality Management System implementation and maintenance to guarantee compliance with applicable standards, guideline and laws

Self-Inspections and internal audits- assessment and optimization of internal processes

Mock recalls – verifying the effectiveness of procedures

Complaints handling – effective management of customer complaints

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If you need help or have questions, our team is here to assist you.