Streamlined regulatory solutions.
From documentation to project coordination, ensuring your products meet all standards efficiently.
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Pharmacovigilance solutions.
We offer pharmacovigilance expertise, covering qualified person responsible for pharmacovigilance (QPPV) office services, supported with LCPPV in CEE, continuous safety profile monitoring, and 24/7 availability for authorities.
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Pharmacovigilance services
Standardised vigilance system that complies with good pharmacovigilance practice guidelines.
EVIGROW pharmacovigilance services ensure detection, assessment, and prevention of adverse events related to medicinal products.
We provide follwowing services
EU (QPPV) office services
EU QPPV & deputy QPPV
We offer experienced EU QPPV support for lifecycle safety management and authority engagement.
PSMF (Pharmacovigilance System Master File)
Comprehensive PSMF services include initial setup, regular updates, and annex management.
EudraVigilance
EVIGROW maintain EudraVigilance access and functionality for timely ICSR and xEVMPD submissions.
GVP QMS establishment and maintenance
Our service includes management system setup, SOP development, and continuous improvement aligned with EU GVP standards.
24/7 availability
Our team is available around the clock to ensure timely responses and support.
Global literature monitoring
Our service includes weekly global literature screening, case triage, and documentation for audit readiness.
Safety information management and reporting
Safety information management includes signal tracking, case processing, and documentation.
Medical information service
We ensure accurate, compliant medical information responses to healthcare professionals and patients across therapeutic areas.
Safety information management and reporting
Safety information management includes signal tracking, case processing, and documentation.
Medical information service
We ensure accurate, compliant medical information responses to healthcare professionals and patients across therapeutic areas.
Compliance activities
Our service includes compliance monitoring, deviation tracking, and CAPA implementation.
Medical writings
Our experts create clear, structured safety documents aligned with GVP and global standards.
Local pharmacovigilance services
LCPPVs & deputy
We provide dedicated local contact persons in each country to facilitate efficient communication with national authorities, ensuring compliance and support tailored to regional needs.
24/7 Availability
We ensure 24/7 availability to national authorities for urgent safety issues and communication.
Local legislation monitoring
Local legislation monitoring ensures your PV system aligns with evolving country-level requirements.
Local literature monitoring
We track country-specific publications to detect relevant safety information and ensure PV compliance.
Medical translations
Our professional translation service ensure that all pharmacovigilance documents are accurately translated, maintaining compliance and clarity across different languages and regions.
Pharmacovigilance training
We ensure that local teams understand their PV responsibilities and maintain inspection readiness.
Local aRMMs implementation
We manage local review, submission, and distribution of additional risk minimisation measures.
Local PV documents preparation and submission
Our service ensures compliant drafting and submission of country-specific pharmacovigilance documentation.
Service features
GDPR Compliance
We prioritize data protection by ensuring full compliance with GDPR regulations, safeguarding personal data while supporting your pharmacovigilance activities.
Information security ISO 27001 certified
Our ISO 27001 certified systems ensure secure handling of pharmacovigilance data and regulatory compliance.
Why EVIGROW?
We’ve built strong industry connections and a reputation for success, ensuring smooth and timely submissions & approvals.
Our intelligent solutions seamlessly integrate with Clients' systems, streamlining processes and enhancing efficiency.
Safe & compliant pharmacovigilance.
Stay ahead of safety requirements with our comprehensive pharmacovigilance support.
Precision in translation services.
Accurate, industry-specific translations for regulatory, pharmacovigilance, and clinical trials. Our professional team ensures that your documentation is clear, compliant, and reliable.
Your partner in medical & technical writings.
We offer expert knowledge enhanced by innovative solutions that increases efficiency while maintaining the exceptional service your business deserves.
Questions and answers
Questions we think you might like answers to.
How information security is managed at EVIGROW?
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.
What is qualification of EVIGROW personnel?
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.
We have signed our first in-licensing contract, how EVIGROW can help us?
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.
We are looking for the partner which can maintain our product portfolio in CEE countries, would EVIGROW support us?
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.
Didn't find the answer to your question? You can always check our list of important information here or submit your question to our customer service team: info@evigrow.com
EVIGROW expert services enhance your regulatory affairs, pharmacovigilance and medical & technical writing and will help you streamline compliance, accelerate market access, and ensure operational efficiency.
EVIGROW operates in the CEE region, encompassing the Czech Republic, Hungary, Poland, Romania, Slovakia, Slovenia, and the Baltic states (Estonia, Latvia, and Lithuania).
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