It operates as the key interface between ELPEN and national, European and international regulatory authorities, ensuring timely and efficient management of all regulatory approval procedures.
Cooperation with Regulatory Authorities
The Department maintains systemic and technically substantiated collaboration with:
- The National Organization for Medicines (EOF)
- The European Medicines Agency (EMA) and the National Competent Authorities of EU Member States
- Regulatory Authorities of non-EU countries
- International partners and pharmaceutical companies within the framework of licensing agreements and strategic collaborations
Key Areas of Activity
The Regulatory Affairs Department undertakes a comprehensive range of responsibilities, including:
- Designing and implementing regulatory strategies for new products, new markets and business partnerships, ensuring timely and efficient market access both domestically and internationally.
- Continuously monitoring of the evolving regulatory landscape and translating new regulatory requirements into targeted actions that support the Company's strategic growth and upholdthe highest compliance standards.
- Managing the full lifecycle of Marketing Authorisations (MAs), from initial approval to renewal and variation handling, ensuring that all regulatory activities and submissions comply with current legislation and relevant regulatory guidelines.
- Preparing, coordinating and managing national, European and international regulatory approval procedures, including Decentralised Procedure (DCP), Mutual Recognition Procedure (MRP), as well as processes in non-EU markets.
- Preparing, submitting and maintaining electronic Common Technical Document (eCTD) dossiers in accordance with international standards and authority requirements.
- Providing specialised regulatory guidance to operational units and international partners, contributing to the successful execution of new projects, licensing activities and commercial collaborations, while ensuring strategic alignment and coordinated timelines across all stakeholders.
Support for International Collaborations
The Regulatory Affairs Department offers specialised support to partners and subsidiaries in Greece and abroad, including:
- Guidance on regulatory requirements and approval procedures.
- Communication and coordination with competent regulatory authorities.
- Preparation and submission of licensing dossiers.
- Monitoring the approval progress and managing regulatory queries until successful completion.
With strong scientific expertise, regulatory know-how and an international orientation, ELPEN's Regulatory Affairs Department plays a decisive role in ensuring the quality, compliance and availability of the Company's products, strengthening their presence in global markets.