Quality and Certifications
Quality certifications that we have to guarantee the trust and reliability of our work.
Excellence in Compliance & Quality
Upholding the highest standards in pharmaceutical quality
We are proud of our quality track record: GLP/GMP-certified, GCP compliant, inspected by EMA, FDA, relevant health authorities and periodic client audits. Our three EU sites are systematically monitored by Corporate Quality Assurance to uphold a unified quality system across the group. All analytical work and processes are regulated by Standard Operating Procedures (SOP) in compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) or Good Manufacturing Practices (GMP). A LIMS system is implemented for instruments integration, data integrity and traceability. We are Certified EU Importers of medicinal products with Quality Control managers for batch testing and Qualified Persons (QPs) for batch release certification.
Our latest FDA inspections were successfully completed on May 2020 (Kymos; FEI #3008661256) and April 2019 (Pharmaprogress; FEI #3002860914).
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