Pharmassist

Pharmassist is a full‑service Contract Research Organisation (CRO) that has been delivering integrated solutions since 1999 across Clinical Operations, Pharmacovigilance, Regulatory Affairs, and Medical Affairs. Leveraging deep expertise in European regulatory and Clinical frameworks (including CTIS, EudraVigilance, MRP/DCP, and Centralised procedures) Pharmassist delivers core clinical, regulatory, and pharmacovigilance services on a pan‑European basis from its central operations. This operational model ensures efficient project execution and consistent quality, while local regulatory and operational requirements are addressed through an established network of qualified partners and subject‑matter experts across multiple jurisdictions.

 Beyond the European Union, Pharmassist supports a diverse portfolio of pharmaceutical clients on international projects spanning the United States and the rest of the world.

Core Capabilities 

Clinical Operations

Pharmassist has participated in more than 130 clinical studies, involving over 160 Key Opinion Leaders, 1,400 investigational sites and more than 20,000 patients. The Company has experience across major therapeutic areas, including Oncology, CNS, Respiratory, Cardiology, Ophthalmology, Metabolic Diseases, Interventional Radiology, Haematology and Hepatology. The Clinical Department has been successfully inspected by the Hellenic National Organisation for Medicines (EOF).

Medical Affairs

The Medical Affairs team supports all core functions of the Company, including clinical trial execution, regulatory documentation and pharmacovigilance activities. Services include medical writing, medical monitoring, promotional material review, scientific training, advisory board support and early access programs. The team also provides full support for EU MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) requirements.

Pharmacovigilance (PV)

Pharmassist collaborates with more than 60 pharmaceutical companies, acting as EU QPPV for 40 of them. The PV system has undergone more than 60 external audits over the past five years with no critical findings. The department has also been successfully inspected by the Hellenic National Organisation for Medicines (EOF).

Regulatory Affairs

The Company has extensive regulatory experience, supporting more than 100 clients globally. Pharmassist has participated in over 600 MRP/DCP/NP procedures and managed more than 3,500 CMC variations. The Company has also supported major pharmaceutical mergers and acquisitions through regulatory due diligence and gap analysis of quality and CMC documentation.

 Quality Assurance

Pharmassist operates under a certified Quality Management System (ISO 9001:2015, ISO 13485:2016, ISO 27001:2013). The Quality Assurance function supports internal operations as well as external clients through SOP development, audit readiness, third-party audits and compliance with GxP standards.