Our Services
End-to-end consulting for every stage of the pharmaceutical product lifecycle — regulatory, quality, safety and market access.
A complete lifecycle partner
From first regulatory strategy to reimbursement and ongoing compliance, PQRA covers the full range of services pharmaceutical and healthcare companies need in Greece and the EU.
Regulatory Affairs
Get your medicinal products to market with comprehensive regulatory support.
- Regulatory strategy for national, MRP/DCP and centralised (EMA) routes
- Marketing Authorization Application (MAA) preparation and submission
- Dossier compilation and lifecycle maintenance in eCTD / NeeS format
- Variations, renewals and line extensions
- EOF liaison and local representation
- Labelling, SmPC, PIL and mock-up review
Market Access & Reimbursement
Turn a marketing authorization into real patient access.
- HTA dossiers and submissions to EOPYY / the Assessment Committee
- Cost-minimization, budget-impact and cost-effectiveness analyses
- Pricing strategy and Price Bulletin support
- Value dossiers and payer evidence
Quality Assurance & Compliance
Meet international quality standards with confidence.
- Design, implementation and maintenance of Quality Management Systems (QMS)
- GMP / GDP compliance and audit readiness
- ISO systems and internal auditing
- Supplier and distributor qualification
- Inspection preparation and support
Pharmacovigilance & Medical Information
Protect patients with proactive drug-safety systems.
- Set-up and running of PV systems and the PSMF
- Local and EU QPPV / safety-officer support
- ICSR case processing and EudraVigilance reporting
- Signal management, PSURs / PBRERs and risk-management plans
- Medical information services
Marketing & Business Consulting
Grow with strategy grounded in regulatory reality.
- Go-to-market and launch strategy for pharma and medical devices
- Regulatory-compliant promotional material review
- Portfolio and business development advisory
Medical Devices
Support across the EU MDR framework.
- Classification and conformity-assessment strategy
- Technical documentation review
- Registration and vigilance support
Audits & Inspection Readiness
Know you are ready before the inspector arrives.
- GMP and GDP audits and gap assessments
- Supplier, distributor and CMO qualification audits
- Mock inspections and inspection readiness
- Internal and self-inspection programmes
- CAPA definition and follow-up
Training & Workshops
Practical, up-to-date training for your team.
- GMP, GDP and quality systems training
- Pharmacovigilance, signal detection and PSMF
- Regulatory affairs, eCTD and variations
- Market access and HTA essentials
- Tailored in-house workshops
Software Solutions
Selection, implementation and validation of the digital systems that run a compliant life-sciences operation.
- Regulatory Information Management (RIM) and eCTD publishing systems
- Electronic Quality Management Systems (eQMS) and document control
- Pharmacovigilance and safety databases with EudraVigilance connectivity
- Learning Management Systems (LMS) for GxP training and records
- Computer System Validation (CSV) to GAMP 5 and Annex 11 / 21 CFR Part 11
Not sure where to start?
Book a meeting and we will map the fastest compliant route to market for your product.
Book a Consultation