Konstantinos Kritikos

PHARMASSIST LTD

PHARMASSIST LTD, is a fast-growing, full-service Contract Research Organization located in Athens-Greece (headquarters), London-UK and Nicosia (CY). The company operates in Europe since 1999, providing services in Clinical Trials, Medical Affairs, Pharmacovigilance, Regulatory Affairs and Quality Management. Pharmassist has extensive Clinical trials experience in all therapeutic areas, with more than 83 trials of several designs/phases (interventional, Phase II–IV, national, multinational, observational), over 16.000 patients recruited and 1180 Study Centers. Certified by the French Ministry of Higher Education and Research as an approved organisation for carrying out R&D activities for the account of private companies. Pharmacovigilance dpt counts over 50 active clients, providing EU QPPV for 35 pharma companies and Local QPPV/Deputy for 15 multinational pharma companies. Our PV Quality System has been assessed via 30 external Audits by international pharma companies/Contract Safety Surveillance Organisations (CSO) with successful outcomes. Our Regulatory Affairs dpt counts over 100 clients, almost half being top multinational pharma companies. With more than 100 due diligence dossier reviews, including gap analyses of Quality and CMC documentation, hundreds of MRPs/DCPs/NPs and thousands of CMC variations as well as a trusted partner during several major multinational pharma mergers and acquisitions for Marketing Authorisation transfers and other regulatory activities. With an established network in 33 EU countries, providing full regulatory support for more than 10 multinational pharma companies. As drug development is at the heart of your organization, we tailor our programs and our operations to our clients' unique needs towards a joint success. Our highly proficient personnel as well as our expanded network provides a complete, thorough and high-level support at a global level. Certified since 2011, according to ISO 9001 standards.