What we do
At PQRA, we specialize in providing top-notch management consulting services.
We go beyond just offering advice – we develop custom solutions for your unique business needs. Our goal is to help you achieve growth and achieve more than you ever thought possible.
Our Services
We offer a wide range of consulting services to assist companies in the pharmaceutical industry.
Regulatory Affairs & Market Access
Expertise in navigating the complex process of obtaining Marketing Authorizations in Greece and the EU.
Quality Management & Audit Readiness
Development and maintenance of Quality Management Systems (QMS) and support for compliance with ISO and GXP regulations.
Pharmacovigilance & Medical Information
We ensure patient safety and legal compliance through reliable safety monitoring and medical iinformation systems in the field of pharmaceuticals.
Success Through Experience
With over 25 years of industry experience, PQRA has developed a deep understanding of the EOF and European regulatory frameworks.
We believe in tailored strategic advice. We know that one size does not fit all and every submission is optimized for your specific product portfolio. At PQRA, we are committed to your success.
About PQRA
Empowering pharmaceutical companies, medical device manufacturers, and healthcare innovators worldwide.
We ensure compliance with EOF and EMA regulations, simplifying complexity and reducing time-to-market.
Regulatory Affairs (RA)
Get your medicinal products to market with our comprehensive support services.
Dossier Compilation (eCTD/NeeS)
Our team ensures your dossier is complete and compliant for MAA submissions.
Quality Assurance (QA) & Compliance
We guarantee your operations meet international quality standards and regulations.
Pharmacovigilance (PV)
Stay ahead of drug safety with our proactive PV services and reporting.
Our Recent Projects
At PQRA, we pride ourselves on delivering excellence across the product lifecycle for our clients in the pharmaceutical industry.
Client Testimonials
Here’s what our clients have to say about working with us:
The team at PQRA was instrumental in our recent eCTD submission to the EOF.
Regulatory Strategy Testimonial
Astra Zeneca
We approached PQRA to help us prepare for a high-stakes GMP inspection. We passed the inspection with zero critical findings.
Quality & Auditing Testimonial
Innovis Pharma
Setting up a robust Pharmacovigilance system can be a daunting task, but PQRA made the transition seamless.
Pharmacovigilance Testimonial
Vianex
What are you waiting for?
Ready to take the next step? Let’s bring your vision to life! Explore our services and get in touch today for a consultation. Together, we’ll make it happen.
Expert Guidance from Industry Veterans
Meet our team of experienced consultants who are here to provide you with expert guidance in the complex world of regulatory affairs.
Dimitrios Gkikas
Principal Consultant & Founder
Specializing in Strategic Regulatory Affairs and EOF Liaison
Isabelle Moreau
Head of Quality Assurance & Compliance
Expert in GMP, GDP, and ISO Systems
Lukas Weber
Senior Pharmacovigilance Officer
Specializing in Drug Safety and EudraVigilance
Marta Lindqvist
Head of Market Access & HTA
Specializing in Reimbursement, Pricing and HTA
Proven Excellence in Regulatory & Quality Affairs
Decades of navigating the evolving EOF and EMA regulatory landscapes.
Years of Expertise
25+
Successful Submissions
500+
Quality Audits Conducted
120+
Compliance Rate
100%
Explore Our Blog
ISO 27001 and Data Integrity: Information Security Risks in a GxP Environment
Information security has quietly become a GMP concern. As[…]
The EU Medical Technology Framework: A Compliance Roadmap for 2026 and Beyond
The European Union’s medical technology rulebook — the Medical[…]
Biosimilars in Europe: Interchangeability and the New Tailored Clinical Approach
By 2026 the European biosimilar framework has matured from[…]
Contact Information
To contact us, you can reach us via telephone or email.
Email: info@pqra.gr
Address: Leof. Kifisias 44, Marousi 151 25
Phone: 21 0444 1982