Meditrial Internationals

Meditrial Internationals is rated 3 out of 5 in the category pharmaceuticals. Read and write reviews about Meditrial Internationals. Meditrial is Bulgarian CRO which provides high quality support services to the pharmaceutical industry in the fields of clinical trials, bioanalytical services and regulatory affairs services. The domain of our experience and activities includes: - Clinical Trials Project Management, Monitoring, Preparation of clinical trial documentation (CTP, IB, CRF, ICF), Insurances, Regulatory Services, Drugs logistic, Biological samples logistic, Data Management, Statistical Analysis, Preparation of Integrated Study Report, Archiving All our services are carried out in accordance with ICH-GCP guidelines. Meditrial proved its quality of work with excellent results from sponsor audits, local regulatory inspections and FDA inspection. - Laboratory analyses Meditrial Lab is GMP and ISO/IEC 17025 certified control laboratory. Our analytical team has extensive experience in analytical testing. We offer innovative technologies, expertise, flexibility, and rapid assay results. Our services: Batch control analysis, EU Batch release, Validation and transfer of existing methods, Development of new methods, Analytical reports, Batch control analysis, Pharmaceutical tests, Electrochemical tests, Physical tests, Special tests, Stability tests. - Regulatory affairs services Our team has the ability and experience to handle Clinical trial applications, Marketing authorization applications, price and reimbursement support and support post marketing obligations for medicinal products and medical devices. Our local experience and excellent relationship with key regulators assist clients with projects in Bulgaria and EU. We work according to the highest regulatory compliance standards.