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Delivery, importation, storage, local distribution and other related logistic service of Investigational Medicinal Products and other study related products can pose a significant challenge to customers meaning safety of investigational subjects and quality of data receved within Clinical Trials.
We provide our customers’ with service in obtaining of import and export licenses, planning of logistics, usage of appropriate storage facilities for investigational products and full range of IMP logistic management.
Medicore operates in compliance with Good Storage Practice for Pharmaceuticals and its own Standard Operating Procedures which are compliant with GMP, GCP, GDP (94/C63/03, 92/25/EEC) and CFR 21 part 211, other European and local regulations.
Medicore has internal Quality Assurance System to ensure processes and procedures are updated on a permanent basis and meet applicable regulatory requirements.
Services provided by Medicore:
- Customs clearance of Investigational Products
- Cold storage conditions and cold chain maintenance
- Distribution of Investigational Products to investigational sites, within given time frames according to sponsors/ CRO requirements (cold chain transportation, if required)
- Reconciliation & destruction of the Investigational Products
Scope of Medicore services includes:
- Investigational Product Handling procedure development if required
- Receipt and Storage of the Investigational Product
- Distribution of the Investigational Product (cold chain transportation, if required)
- Re-labeling of the Investigational Product
- Centralized Destruction of the Investigational Product
- Return of the Investigational Product to the Sponsor
- Approved concomitant treatment(s) purchasing, storage and distribution
- Full range of logistic services in term of other study related materials handling (CRFs, Lab. Kits, related equipment etc.)
- Storage of Clinical Studies archives
Characteristics of Medicore warehouse facilities:
- Restricted, secured access to the storage facilities
- Separate quarantine zones & chamber
- Computerized temperature control
- Allow to store medications at different temperature modes, Study Protocol conditions and sponsor's requirements
- +2 - +8 C and ambient storage options
- Alarm systems with preset values responding to power failures and temperature fluctuations
- Automatic back-up power supply
For more detail and specific information please contact
Dr. Andrey Zaremba, Head of Medical Department
tel/fax: +38 044 239 0755 (ext. 1900)
+38 044 581 2445
mob.: +38 067 548 0169
azaremba@medicore.com.ua
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