Our Services
End-to-end consulting for every stage of the pharmaceutical product lifecycle — regulatory, quality, safety and market access.
What We Do
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.
1
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
2
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
3
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
4
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
5
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
6
Medical Devices
Support across the EU MDR framework.
- Classification and conformity-assessment strategy
- Technical documentation review
- Registration and vigilance support
Not sure where to start?
Book a meeting and we will map the fastest compliant route to market for your product.
Book a Consultation