Your Partner for Global Regulatory, GMP Services & Third-Party Audits.
Your Partner for Global Regulatory, GMP Services & Third-party audits.
Metina Europe Kft.

Metina Europe Kft.

Metina is excited to announce the opening of its Europe office in October 2024, enabling us to deliver comprehensive services for markets in EU and UK. This milestone strengthens our ability to provide End-to-End Services for EU markets to clients across the globe!

Metina Europe Kft.
White Office building, 14, 10 Fehér Road, District X, 1106 Budapest, Hungary.

Email
info@metinaeurope.com

Our Expertise

Metina Europe Kft. offers support for pharmaceutical and biopharmaceutical companies aiming to enter the European market, including the following services:

Marketing Authorization Holder (MAH) & Manufacturing and Import Authorization (MIA)

  • Market Authorization Holder (MAH) services to client for obtaining and maintaining the marketing authorization, managing pharmacovigilance, and ensuring compliance with all relevant EU regulations until a commercial partner is finalized
  • Qualified Person for Pharmacovigilance (QPPV) services towards compliance with PV requirements. QPPV will ensure that adverse drug reactions are reported, risks are assessed and minimized, and information on safe product use is provided
  • Submission of periodic safety update reports (PSURs) to regulatory authorities

Batch Testing and Release

Metina ensures seamless compliance with EU regulatory standards for batch testing and Qualified Person (QP) batch release. Our network of certified testing laboratories and release sites adheres to Good Manufacturing Practice (GMP) requirements, providing precise quality testing, stability studies, and batch certification.

Local Regulatory Representative in Hungary

As a part of local module 1 requirements, Metina provides services of local regulatory representative in Hungary as the authorized HU agent on behalf of Metina for addressing queries, handling of product related questions from the Agency during regulatory submission stage in the local official EEA language of the country (Hungarian), to communicate and liaise with agency. The local representative holds access to the official web portal facilitating submission of MAA on the portal.

Pharmacovigilance & QPPV Services

Metina provides comprehensive pharmacovigilance services, including Local Qualified Person for Pharmacovigilance (Local QPPV) support, ensuring compliance with European Union regulatory requirements. Our services cover signal detection, risk management, and the submission of Individual Case Safety Reports (ICSRs) in alignment with EMA and local authority guidelines. With a team of experienced Local QPPVs on board, we offer proactive monitoring and management of safety risks while ensuring timely regulatory reporting. Partner with Metina to uphold the highest standards of product safety, maintain regulatory compliance, and build trust with consumers across European markets.

EU QP Audits

Metina specializes in conducting comprehensive audits to meet EU Qualified Person (QP) requirements, ensuring full compliance with Good Manufacturing Practice (GMP) standards. Our services include thorough assessments of manufacturing facilities, quality systems, and supply chain processes, with a focus on identifying risks and implementing corrective actions.