Streamlined regulatory solutions.
From documentation to project coordination, ensuring your products meet all standards efficiently.
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Regulatory affairs solutions.
EU marketing authorisation projects coordination and local regulatory support in CEE countries, accompanied with medical and technical writings, eCTD compilation, translations and market access services.
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Regulatory affairs services
Tailored to your regulatory project needs in every step of the lifecycle starting from preparation of dossier documentation.
From initial advice to comprehensive solutions, we are your trusted partner for navigating the complexities of multiple markets, whether it's medicines, medical devices, food supplements, or cosmetics. Our services include dossier preparation, writing modules and documents, scientific advice procedures, submissions, and coordination. Let us streamline your regulatory journey and ensure your products meet all necessary standards.
We provide follwowing services
Local regulatory affairs services
Medicines authorisation and post-authorisation
Preparation of local dossier documents, applications, requests and translations. Acting as local contact, ensuring timely approvals and compliance.
Parallel import/distribution authorisation
Obtaining parallel import/distribution marketing authorisation of medicinal products (national procedure, centralised procedure)
Medical devices notification
Handling of notification processes for medical devices to National Competent Authorities.
Food supplements notification
Handling of notification processes for food supplements and preparation of labelling texts according to local and EU legislation.
Artwork management
Proofreading and approval of artworks in national languages. Provision of comprehensive solutions for multilingual packaging in accordance with local regulatory requirements.
Advertising materials
Ensuring medicinal products, food supplements, medical devices and cosmetics advertising materials compliance with EU guidelines and country specific requirements .
Market access
EVIGROW will support through the processes of national price declarations and reimbursement applications.
Local regulatory intelligence
Expert guidance on country-specific regulatory requirements across EU member states.
Market access
EVIGROW will support through the processes of national price declarations and reimbursement applications.
Local regulatory intelligence
Expert guidance on country-specific regulatory requirements across EU member states.
Professional regulatory affairs services
Technical and medical writings
EVIGROW writes dossier documentation for marketing authorisation and post-authorisation phases, including overviews and summaries, RMPs, PSURs, ERA waiver.
Scientific advice procedures
We guide companies through the scientific advice process - from question development, documentation, and meeting preparation to follow-up analysis.
EU dossier services
Dossier audit, building of approval ready dossier(s), submission and coordination of procedures. EVIGROW supports with national, mutual recognition, decentralised and centralised procedures in EU.
Post-authorisation dossier services
Renewals of marketing authorisation, Type IA, IB and II variations, Article 61(3) notifications, MA transfers and classification changes as well as other changes of approved information required to maintain state-of-art information in the product dossier.
Regulatory strategy
Focused EU regulatory strategy planning for pharma and biotech. Supporting in managing complex requirements with structured, compliant approaches.
Medical devices certification coordination
We offer the CE certification process coordination and documentation preparation for medical devices.
eCTD dossiers compilation & submission
eCTD dossiers publishing for national, mutual recognition, and decentralised procedures
EVIGROW specializes in publishing of eCTD dossiers (sequences) for national, mutual recognition, and decentralized procedures.
Reformatting dossiers of medicinal products to eCTD format
EVIGROW provides expert reformatting services to convert your existing medicinal product dossiers from paper or other electronic format into eCTD.
eCTD dossiers publishing for non-EU countries
We offer tailored eCTD dossier publishing services that comply with the requirements of non-EU countries.
Publishing of paper copies of electronic dossiers
In addition to our electronic submission services, we offer publishing of paper copies of electronic dossiers.
Readability testing solutions
Performing readability testing of package leaflet
EVIGROW specializes in performing thorough readability testing of package leaflets to ensure they effectively convey essential information.
Preparation of bridging report
We provide comprehensive bridging reports to support your marketing authorisation applications.
Identifying of weak spots
Our expert team identifies key areas within your package leaflet that require attention for improved readability.
Elaboration of testing strategy
We develop tailored testing strategies to assess the readability of your package leaflets effectively.
Preparation of package leaflet to be in-line with CMD(h) guidelines
EVIGROW ensures that your package leaflets are meticulously prepared in compliance with CMD(h) guidelines.
Translation of package leaflet
EVIGROW offers professional translation services for your package leaflet, ensuring that your materials are accurately conveyed in multiple languages.
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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