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EVIGROW have implemented multiple information safety measures, company information security system is ISO 27001 certified by TÜV Thüringen (Germany) for regulatory affairs, pharmacovigilance, medical writings and translation services, and complies with GDPR requirements.
In the begining of 2025 in EVIGROW approx. 40 experts and specialists were working in regulatory affairs, pharmacovigilance, medical writings and translation fields. Majority of personnel has university degree in pharmacy or in medicine. In addition EVIGROW has internal trainings system, in order to maintain state of the art personnel knowledge of legal, regulatory and pharmacovigilance requirements.
EVIGROW will identify gaps and will develop action plan for reaching marketing authorisations in target markets within shortest deadlines. This includes dossier audit/gap analysis, writing and development of missing modules and documents, eCTD compilation, submission arrangements and active support until obtaining of marketing authorisation. Providing, support with establishing pharmacovigilance system with EU QPPV office and/or local pharmacovigilance setup. After Marketing Authorisation is obtained we will continue to support through all the product lifecycle.
EVIGROW offers regulatory affairs and pharmacovigilance services across the region, including the Baltics (Estonia, Latvia, Lithuania), Bulgaria, Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia. Depending on Clients‘ expectations EVIGROW will seamlessly integrated with Clients‘ project management approaches and electronic regulatory and pharmacovigilance management systems. EVIGROW has developed internal trainings library and, if needed, is able within shortest deadlines involve additional personnel into new projects.