Regulatory support that enables compliant market entry and lifecycle success.
At EL PHARMA Representation Services of PHOENIX group, we are committed to delivering Regulatory Affairs services that adhere rigorously to both European and local legislation, guaranteeing compliance for all products under our management.
From essential support activities to full-fledged services depending on the partnership model and/or the countries in scope.
Regulatory strategy, application, and post-approval lifecycle management across non-EU PHOENIX markets.
Local representation before health authorities, regulatory intelligence, product information and artwork management, and regulatory approvals for repackaging, foreign packs and promotional materials.
Local regulatory support related to distribution, including communication with local health authorities, management of regulatory fees and required notifications.
From essential regulatory support to full-service solutions, depending on the partnership model and markets in scope.
Whether it is navigating complex regulatory requirements or providing guidance on compliance matters, our dedicated team is equipped to assist at every stage of the regulatory process.
With extensive track of records in successfully serving partners across pharmaceutical industry, we are committed to bridging the healthcare gap across Europe.