Welcome Services Softwares Team Contact Documents Privacy Policy Return To Top

Welcome!

At SolDRA, we bring together deep industry knowledge and hands-on regulatory experience to help pharmaceutical and biotech companies navigate the complex world of European drug regulation.

For more than 15 years, our team of regulatory professionals has supported companies of all sizes — from emerging innovators to established global players — providing tailored, end-to-end regulatory solutions that ensure compliance, efficiency, and peace of mind.

Trusted by over 50 clients across Europe, we take pride in building lasting partnerships grounded in transparency, expertise, and results.

Let’s make your next milestone a success — together.

Our Key Services Include:

GXP Audits and Inspections

GXP Audits & Inspections: Full compliance with EU standards for Good Manufacturing, Distribution, and Laboratory Practices.

GDP-Compliant Transport & Warehousing

European Affiliate Office Setup: Establish a seamless local presence for your pharmaceutical operations.

GDP-Compliant Transport & Warehousing

GDP-Compliant Transport & Warehousing*: Secure and compliant logistical solutions for pharmaceutical storage and distribution.

Import, Packaging, and Certification

Import, Packaging, and Certification: End-to-end management of product import, packaging, labeling, batch testing, and EU certification.

Regulatory Affairs

Regulatory Affairs: Complete submission management, eCTD support, readability testing, and multilingual translation services.

Pharmacovigilance

Pharmacovigilance: EU QPPV and local pharmacovigilance services to ensure ongoing safety monitoring.

Quality Assurance

Quality Assurance: Comprehensive support with Responsible Person (RP) and Qualified Person (QP) services, ensuring product quality and safety.

Softwares

Advanced Pharma Software Solutions:

DREAM : Our Drug Regulatory Electronic Affair Management tool streamlines regulatory submissions and compliance tracking, helping pharmaceutical companies accelerate timelines and minimize errors.

  • Product Registry : Manage product data lifecycle in alignment with EU marketing authorization.
  • Compliance Tracking : Stay on top of submissions, deadlines, and regulatory approvals.
  • Collaboration Tools : Enhance teamwork between regulatory, R&D, and quality control teams.
  • Automated Workflows : Streamline key processes to reduce manual intervention.
  • Document Management : Secure and centralized document repository with version control.

DOCUFLOWER : A user-friendly cloud platform for managing SOPs and training programs, designed specifically for the pharmaceutical industry.

  • Compliance Tracking : Ensure all staff complete required training and SOP reviews in line with regulatory standards.
  • Version Control : Keep SOPs up-to-date and easily accessible.
  • Role-Based Access : Provide secure, customized access for different team members.
  • Mobile Access : Access SOPs and training from any device, anywhere.
  • Automated Reporting : Generate detailed reports for audits and training progress tracking.

Team

Gergely ZAJZON MD - CEO

Kinga HEGEDÜS PharmD - Head of QA, GDP

Tatiana ĎURDIAKOVÁ PhD -
Head of Pharmacovigilance, Managing director of SolDRA International SRO (Slovakia)

Hedvig BORUZS PharmD - Head of Regulatory Affairs