Quality Assurance Services
CROMOS PHARMA Quality Assurance (QA) services
We provide Quality Assurance services through dedicated, qualified and trained experts with vast local experience in Russia and Ukraine. Our QA experts will complete specific tasks for our Clients while taking into consideration local cultural factors and differences in medical practices. You may rely on our QA auditors to strictly follow your instructions and timelines. We can help our Clients establish complete Quality System for the whole project or provide support with specific tasks. Please contact us to discuss how we can add value to your projects in the following areas:
- Investigational Site Audits in Russia and Ukraine
- Pre-qualification Audits of Vendors (CROs, Laboratories, Warehouses, etc.)
- Setup of Quality Management System
- GCP Training and Coaching
- Support to foreign auditors in Russia and Ukraine
Investigational Site Audits in Russia and Ukraine
To assure compliance with ICH GCP guidelines, FDA and local regulations before, during or after a clinical study we will conduct independent review of investigational sites. We can also help you with assessment of adequacy of corrective and preventive actions to be undertaken, as well as with audit follow-ups to verify that appropriate actions were taken.
Pre-qualification Audits of Vendors (CROs, Laboratories, Warehouses, etc.)
Independent audits of vendors to give assurance that the organization/institution is fully compliant with international and local guidelines for clinical research and able to provide the services that are required.
Setup of Quality Management System
To assure compliance with GCP requirements we provide input in SOPs preparation, standardization and organizational development. We may conduct internal audit activities including review of study reports, study protocols, informed consents, etc.
GCP Training and Coaching
Individually designed courses to update clinical research personnel on GCP requirements and your Company’s SOPs, additional individual support can be provided by QA specialists on general issues related to GCP and particular studies.
Support to foreign auditors in Russia and Ukraine
We provide full support (including translation, transportation, support during the audit, etc.) to auditors traveling to Russia and Ukraine.
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