{"id":33,"date":"2025-08-07T09:46:58","date_gmt":"2025-08-07T09:46:58","guid":{"rendered":"https:\/\/reglex.ee\/avaleht\/"},"modified":"2025-10-24T01:53:18","modified_gmt":"2025-10-24T01:53:18","slug":"avaleht","status":"publish","type":"page","link":"https:\/\/reglex.ee\/en\/","title":{"rendered":"Avaleht"},"content":{"rendered":"
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Your Partner in Regulatory Affairs and Marketing Activities<\/h1>\n\n\n\n

We offer tailored, hands-on support across human pharmaceuticals, and medical devices \u2014 providing adaptable solutions to meet the unique needs of companies ranging from startups to established enterprises.<\/p>\n\n\n\n

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Services<\/h2>\n<\/div>\n<\/div>\n\n\n\n
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Human Medicines<\/h3>\n\n\n\n

Regulatory Affairs \u2014 Marketing Authorisations and Maintenance<\/p>\n\n\n\n

Pharmacovigilance<\/p>\n\n\n\n

Marketing Materials and Translation<\/p>\n\n\n\n

Labelling<\/p>\n\n\n\n

Market Access and Price Agreement Negotiations Support<\/p>\n<\/div>\n\n\n\n

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Medical Devices<\/h3>\n\n\n\n

Registration of MDs and Post-Marketing Activities<\/p>\n\n\n\n

Marketing Materials and Translation<\/p>\n\n\n\n

Labelling<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n\n

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About Us<\/h2>\n\n\n\n

With over a decade of hands-on experience in the pharmaceutical and healthcare sectors, we bring a comprehensive skill set in regulatory affairs, market access, pharmacovigilance, and sales. Our professional background spans both human medicines and medical devices, covering the entire product lifecycle \u2014 from market entry to post-market activities.<\/p>\n\n\n\n

In human medicines, we have led the preparation and maintenance of new marketing authorisations, managed pharmacovigilance activities, and developed compliant marketing materials and labelling in close alignment with national and EU regulatory frameworks. Our experience include conducting price and reimbursement negotiations with authorities, planning market access strategies, and building strong stakeholder relationships to support product uptake.<\/p>\n\n\n\n

In the medical devices sector, we have successfully supported regulatory registrations, post-market surveillance, and technical documentation. Our role has also included managing translations, adapting labelling to local requirements, and ensuring marketing materials meet all compliance standards.<\/p>\n\n\n\n

Our leadership role in different organisations has reinforced our practical knowledge of medication safety, patient engagement, and interdisciplinary cooperation, while strengthening our ability to navigate Estonia\u2019s healthcare and pharmaceutical landscape effectively.<\/p>\n\n\n\n