Pharmassist Ltd is a full-service Contract Research Organisation located in Athens-Greece, with two subsidiary companies (London, United Kingdom and Nicosia, Cyprus). It operates in Europe since 1999 providing services in Clinical Trials, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Quality Management and has been certified according to ISO 9001, ISO 13485 & ISO 27001 requirements. The company’s collaborations include major multinational and national pharma companies, international CROs and Academic Institutions and has an established network of experts in all European Countries. Frequently audited for quality of services and Quality System and has successfully undergone 2 Ethical/Workplace Conditions Assessment (WCA) as well as 2 inspections on behalf of the National Organization for Medicines (EOF).
Pharmassist is a member of the Hellenic Bio Cluster (HBio), the first biosciences cluster in Greece, established since 2006. Ioanna I. Koukli, Pharmassist’s Owner and CEO, and currently Presiding HBio, has always been active in the Pharmaceutical Science Industry serving in many policy making committees advocating for health innovation and has developed extensive expertise and “know-how” on developing new health technologies, taking research to the market and reaching new markets way beyond Greece.
Pharmassist counts 26 years of experience in Regulatory Affairs, with more than 100 clients (Local and Foreign/Multinational Pharma Companies) through the years. and an established network of experts in 33 European Counties.
Pharmassist PV Department has established collaborations with more than 70 National or Multinational Pharmaceutical Companies, for 40 of which Pharmassist acts as the EU QPPV. Our PV Quality System has been assessed via 90 external Audits, since 2016, by pharmaceutical companies/Contract Safety Surveillance Organisations (CSO) with successful outcomes (no critical findings).
Pharmassist Clinical Operations Dpt counts 19 years of experience in Clinical Trials in a wide range of Therapeutic Areas with a Team of experienced professionals. Participation in 54 Interventional trials, 26 studies with medical devices and 72 Non-Interventional trials, registries and studies for food supplements, collaboration with more than 160 Key Opinion Leaders and 1.450 study investigational sites and 22.000 subjects recruited. Pharmassist Clinical team undertook the preparation of essential documentation, the submissions to the authorities and the monitoring of 2 national studies for COVID19. Also, the company participated in 2 multinational projects (SOLIDACT & DISCOVERY) in 3 large referral sites for COVID19. Undergone a five-day GCP Inspection in 2021 for two clinical studies by the National Organization for Medicines (EOF) with no critical findings.
Our Medical Affairs Dpt counts 18 years of experience in a wide range of Therapeutic Areas with a Team of Medical/Scientific experts, experienced on Clinical Studies/Investigations (feasibility studies, training on therapeutic area and protocol, medical monitoring), Regulatory Affairs (medical translations, medical review of product’s regulatory documents (SPC, PIL)), Pharmacovigilance (Medical review of ICSRs, aggregate reports) and Other Services (Promotional material review, trainings, medical information, product defense, organization of advisory boards, early access programs). Services provided for > 60 medical devices in various therapeutic areas. More than half are borderline medical devices and at least 9 carry medicinal substances (Class III). Ensured certification of 38 medical devices in 3 different EU Notified Bodies, reduced certification time to less than a year, with no significant findings in clinical evaluation. Generated de novo PMS system and PMS documentation in 5 clients last year, undergone successful audits with no findings. To know more