About PQRA
Regulatory, quality and market-access experts for the pharmaceutical and healthcare industry — turning regulatory complexity into a clear path to market.
Your partner from strategy to market
PQRA is an Athens-based consultancy serving pharmaceutical companies, medical device manufacturers and healthcare innovators across Greece and the wider EU. For more than 25 years we have guided products through the full regulatory and reimbursement lifecycle — from first strategy through Marketing Authorization, market access and ongoing compliance.
We work as an extension of your team. Whether you need a single dossier compiled or an end-to-end regulatory, quality and pharmacovigilance function, we bring the expertise, the local EOF relationships and the EU-wide perspective to get it done.
What sets us apart
Deep local knowledge
Day-to-day experience with the Greek National Organisation for Medicines (EOF) and the EOPYY reimbursement process, backed by fluency in EMA procedures.
Tailored, not templated
Every submission is optimised for your specific product and portfolio. We do not believe one size fits all.
End-to-end coverage
Regulatory Affairs, Market Access, Quality Assurance and Pharmacovigilance under one roof — so nothing falls between the gaps.
Senior people, every project
You work directly with experienced consultants, not junior staff learning on your account.
Our mission
To simplify complexity and reduce time-to-market for the companies that bring important medicines and technologies to patients — while keeping them fully compliant with EOF, EMA and international requirements.
Expert guidance from industry veterans
Dimitrios Gkikas
Strategic regulatory affairs and EOF liaison, with decades of experience steering products through Greek and EU approvals.
Let’s bring your product to market
Explore our services or book a consultation with our team today.
Contact UsOur Regional Presence
Greece, Cyprus and the Western Balkans
Regulatory affairs, quality assurance, pharmacovigilance and market access delivered from Athens across seven markets — with the full EU regulatory network behind every submission.
Where a PQRA submission reaches
A marketing authorisation granted through the centralised procedure is valid in all 27 EU Member States and, through the EEA Agreement, in Iceland, Liechtenstein and Norway. National, mutual recognition and decentralised routes let you select markets individually. We build the route that matches your portfolio and your commercial plan.
Greece — our home market
EOF · Ministry of Health · EOPYY
Direct liaison with the National Organisation for Medicines, the price bulletin process, the Assessment and Reimbursement Committee, the Negotiation Committee and EOPYY. Local representation, Greek-language labelling and the national pharmacovigilance contact point.
Cyprus and the Western Balkans
6 markets
Cyprus, Serbia, Montenegro, Albania, Bosnia and Herzegovina, North Macedonia — national registration routes, local requirements and market access support across the region, coordinated from Athens.
European Union and EEA
30 markets
All 27 EU Member States plus Iceland, Liechtenstein and Norway, reachable from a single centralised marketing authorisation.
Why companies enter Europe through Greece
Greece is a full EU Member State with a mature regulatory authority, and it is one of the most widely referenced pricing markets in Europe. That makes the Greek decision a strategic one, not an afterthought at the end of a launch sequence.
Markets from one dossier
27 EU Member States plus Iceland, Liechtenstein and Norway, from a single centralised marketing authorisation.
Baskets that reference Greece
Greece appeared in 13 of 31 European external reference pricing baskets in the European Commission’s 2013 study — a Greek price does not stay in Greece.
Years of EOF and EMA practice
Regulatory, quality, safety and market-access work across the full product lifecycle.