Full range of regulatory services 
Promotional marketing 
Pharmacovigilance services in Belarus and the EAEU countries 
Product distribution 
User testing of PL Full range of regulatory services
We employ top-notch specialists with decades of experience aware of and utilising all norms of the law of the Republic of Belarus and the law of the EAEU.
Full range of regulatory services
We employ top-notch specialists with decades of experience aware of and utilising all norms of the law of the Republic of Belarus and the law of the EAEU.
To healthcare companies around the world
We can help to authorize your products in accordance with national legislation or the legislation of the EAEU
User testing of the package leaflet
Full range of regulatory services in Belarus since 2020
We expand the number of successful projects and long-term partners year over year.
regulatory services
Marketing authorization of vitally important drug products
regulatory services
Maintaining the life cycle of previously authorized drug products
regulatory services
Authorization of drug products as per the EAEU requirements
regulatory services
Modifications of the dossier for drug products as per the EAEU requirements
regulatory services
Authorization of nutritional supplements
regulatory services
Authorization of medical devices and medical equipment
regulatory services
Authorization and certification of cosmetic products
regulatory services
Authorization of prices for drug products
regulatory services
Coordination of advertising materials
regulatory services
User testing of the package leaflet (PL)
What is
included?
We are a pro team having experience regarding the whole range of pharmaceutical products in original and generic companies, both Belarusian and global.
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Consultations on all authorization procedure issues
Advisory support on regulatory issues within the framework of the national legislation of the Republic of Belarus and EAEU legislation
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Authorization Strategy Development
Authorization strategy selection and justification
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Development of authorization plan and preparation of a list of necessary documents
Development and discussion of a phased plan for the regulatory procedure
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Analysis of the documents submitted
GAP analysis of the registration dossier and individual documents for compliance with law
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Dossier documents formulation
Preparation of registration dossier documents in full compliance with the requirements (layouts, SmPC, PL, regulatory documentation and other documents)
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Translation of documents
Professional translation of registration dossier documents, services for notarial certification of translations and copies of documents
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Dossier generation and submission
Preparation and printing of registration dossier documents for submission
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Interaction with regulatory authorities of the Republic of Belarus
Interaction and communications with regulatory authorities throughout the entire procedure
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Preparation of responses to comments and their submission
Recommendations for corrective actions, preparing and submitting a response to the regulatory authority
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Procedure support
Support throughout the entire procedure, monitoring of submission deadlines
Do you have any questions?
Do not hesitate to contact us in any convenient way and we will advise you on any issue you may have.
Company office manager
