Zdravlje has a 70-year uninterrupted track record of delivering the highest quality products, consistent with the most stringent standards. Zdravlje is EU-GMP approved since 2009 and accommodates various health authority and multinational client audits on a regular basis.
Zdravlje’s Quality Compliance encompasses Quality Assurance (QA), Qualified Person (QP) roles, advanced Physicochemical and Microbiological laboratories, and comprehensive Quality Systems services.
We maintain a high level of quality by ensuring product efficacy and safety. Product Quality Reviews are prepared for Marketing Authorization Holders in compliance with regulatory requirements, utilizing statistical methodologies that cover Critical Quality Attributes, Process Capability, and Continuous Process Verification.
Our experienced and qualified personnel ensure supplier and contractor compliance through a robust auditing management system that includes planning, performance monitoring, Corrective and Preventive Actions (CAPA) follow-up, and effectiveness assessments.
By implementing science-based methodologies, sophisticated equipment, and qualified personnel, our laboratories perform all necessary testing for:
• Excipients and Active Pharmaceutical Ingredients (APIs)
• Analytical Method Transfer
• Stability Studies
• Bulk Products
• Manufacturing & Packaging
Reach out to us and let’s discuss how we can support your pharmaceutical manufacturing needs.
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