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Welcome

SolDRA - Your Comprehensive Partner for European Drug Regulatory Affairs

With over 15 years of expertise in the European pharmaceutical industry and a team of professionals with 10+ years of regulatory experience, SolDRA offers tailored solutions to help you navigate the complex landscape of drug regulation. Join over 50 satisfied clients who trust our expertise.

Our Key Services Include:

  • GXP Audits & Inspections: Full compliance with EU standards for Good Manufacturing, Distribution, and Laboratory Practices.
  • European Affiliate Office Setup: Establish a seamless local presence for your pharmaceutical operations.
  • GDP-Compliant Transport & Warehousing: Secure and compliant logistical solutions for pharmaceutical storage and distribution.
  • Import, Packaging, and Certification: End-to-end management of product import, packaging, labeling, batch testing, and EU certification.
  • Regulatory Affairs: Complete submission management, eCTD support, readability testing, and multilingual translation services.
  • Pharmacovigilance: EU QPPV and local pharmacovigilance services to ensure ongoing safety monitoring.
  • Quality Assurance: Comprehensive support with Responsible Person (RP) and Qualified Person (QP) services, ensuring product quality and safety.

Team

Gergely ZAJZON MD - CEO

Kinga HEGEDÜS PharmD - Head of QA, GDP

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

Hedvig BORUZS PharmD - Head of Regulatory Affairs

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.

Documents

Data Protection

Link to GDPR.pdf

ISO Certificates

Link to ISO9001.pdf

Link to ISO27001.pdf

Privacy Policy

Effective: September 9, 2025

  1. Purpose of the policy The purpose of this policy is to set out the principles and rules of personal data processing carried out by SolDRA International Kft. (the “Company”) in accordance with:
  • Regulation (EU) 2016/679 of the European Parliament and of the Council (GDPR),
  • Act CXII of 2011 on the right to self-determination in relation to information and freedom of information (Infotv.),
  • Act CLIV of 1997 on healthcare,
  • Act XCV of 2005 on medicinal products and the distribution of medicinal products for human use,
  • Decree 44/2004. (IV. 28.) ESzCsM on the marketing of medicinal products,
  • and the pharmacovigilance guidelines of the European Medicines Agency (EMA) (Good Pharmacovigilance Practice, GVP).
  1. Data controller details
  • Company name: SolDRA International Kft.
  • Registered office: [address can be entered]
  • Representative: Dr. Gergely Zajzon, managing director
  • Contact: [e-mail, telephone number]

The Company has not appointed a separate data protection officer (DPO). The person responsible for data protection is: Dr. Gergely Zajzon, managing director.

  1. Legal basis and purposes of data processing 3.1. Readability assessment of patient information leaflets
  • Purpose: to assess whether the patient information leaflets for medicines are understandable to participants.
  • Legal basis: the voluntary, prior and explicit consent of the data subject (GDPR Article 6(1)(a), Infotv. Section 5(1)(a)).
  • Data categories: name, contact details, answers given during the test.
  • Retention period: max. 2 years after the examination is completed, then deletion/anonymization.
  • Data subject rights: access, rectification, erasure, restriction, objection, withdrawal of consent. 3.2. Pharmacovigilance – collection of adverse reactions
  • Purpose: compliance with legal obligations for the sake of drug safety.
  • Legal basis: compliance with legal obligations (GDPR Article 6(1)(c)), public interest in the case of special categories of data (GDPR Article 9(2)(i)), based on Section 17 of Act XCV of 2005 and related implementing regulations.
  • Data categories: health data of the data subject, details of side effects, contact details.
  • Retention period: in accordance with pharmacovigilance legislation, for at least 10 years after the product has been withdrawn from the market.
  • Rights of data subjects: may be exercised to a limited extent if the deletion or restriction of data is not possible due to legal obligations.
  1. Data security The Company applies technical and organizational measures to protect data in accordance with Article 32 of the GDPR and Section 7 of the Infotv.
  • Restricted access
  • Password-protected IT systems
  • Regular data backup
  • Secure storage of paper-based documents
  1. Data transfer

The Company transfers personal data in the following cases:

  • To authorities:

    • to the competent authorities (e.g. OGYÉI, EMA, European Commission) in accordance with the law in the context of pharmacovigilance reports,
    • in the course of fulfilling other obligations specified by law.

  • To marketing authorization holders (MAHs):

    • As the Company performs its PV tasks on the basis of a contract (Safety Data Exchange Agreement – SDEA), it is obliged to forward the received adverse reaction reports and related personal data to the contracting pharmaceutical company(ies) in accordance with the law and the contract.

  • Other third parties:

    • only with the prior consent of the data subject, unless there is a legal obligation to do so.
  1. Rights and remedies of data subjects Data subjects have the right to:
  • request information about the processing of their data (Section 14 of the Information Act),
  • access their personal data (GDPR Article 15),
  • request rectification (GDPR Article 16),
  • request erasure or restriction of processing (GDPR Articles 17-18),
  • withdraw consent (GDPR Article 7(3)).

In case of complaints, data subjects may contact the National Authority for Data Protection and Freedom of Information (NAIH) (1055 Budapest, Falk Miksa u. 9–11., www.naih.hu).

  1. Final provisions

The Company shall review the regulations annually or as necessary.

Date: Budapest, September 9, 2025.

Dr. Gergely Zajzon Managing Director