SmartPharma Group

About

SmartPharma Group is an international pharmaceutical consulting Company, providing regulatory support in EU, CIS, EAEU (including Ukraine and Mongolia) and Balkan region in:
- registration of medicinal products, food supplements, medical devices, cosmetics.
Our services include profound analysis of the dossier, according to the requirements of specific country and selection of the best regulatory access strategy.
And if its requested, preparation of necessary Sections of dossier (including preparation of Modules 2.3, 2.4-2.7, etc.)
- pharmacovigilance (including PV system service, QPPV and LPPV services, monitoring of adverse reactions, monitoring of literature, creating CIOMS reports, PSUR, RMP, SOPs preparation, PV system implementation).
- MA Holder services in the EAEU / EU markets, considering the local requirements for this type of service.
- support in promotion/distribution of products in the CIS and European markets.
- organisation of GxP compliance audits in order to obtain European/Russian/EAEU GMP.
(including preaudit by certified inspectors, development/implementation of the CAPA plan, preparation of manufacturing site / accompaniment of official inspection).

For more information, please, refer to the Company website: https://smart-pharma.group
Please, contact us in case of any questions or clarifications by mail: info@smart-pharma.group
or phone:
+37 052 060 0 94 (LT office)
+38 044 390 31 90 (UA office)

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