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Importation, storage, distribution of IMP among investigational sites along with other study related logistic service can pose a significant challenge to sponsors, meaning safety of subjects investigated, quality of data received within clinical trials and effective time and resources exploration. We provide our customers with full range of local pharmaceutical depot services from the study setting up to closure and archiving. We operate in compliance with Ukrainian regulations, international requirements and best practices applicable to the industry. Our SOPs are compliant with GMP, GDP, GCP (94/C63/03, 92/25/EEC) and CFR 21 part 211, other European and international regulations. |