Regulatory
Affairs

Full life cycle medicinal product management

CE Certification

 

Medical
Writing

Clinical and non-clinical literature overviews

Clinical evaluation reports

Pharmaco-
vigilance

Full range of drug safety related services

LPPV services
EU / UA / EAEU

GxP
Inspections

Assessment of GMP, GVP, GxP compliance

High quality consulting support

Market
Accesses

Analysis of prices, sales and demand

Market overview reports preparation

Quality
Assurance

Development of SOPs

QP services
EU / EAEU

MedSafety app launch in the Kyrgyz Republic
During World Antimicrobial Awareness Week, MedSafety application was launched by the support of WHO and MHRA in the Kyrgyz Republic. Contact us for further information, if you are looking for pharmacovigilance service provider including LCPPV service in this region: info@smart-pharma.group
Important amendments to the EAEU legislative acts
Based on the results of the meeting of the EEC Working Group on Medicinal Products as of 05.10.2020 – 07.10.2020, the following important amendments to the EAEU legislative acts are planned to be introduced: • extension of the transition period to allow manufacturing authorisation of medicinal products under the national legislation of the Member States until the 31st of December 2022; • creation of a Union register for indicated groups …
Kazakhstan approves new Rules for the preparation of PIL and SmPC for medicinal products and medical devices
New Rules for the preparation of patient information leaflet and summary of product characteristics for medicinal products and medical devices was approved by order of the Minister of Health of the Republic of Kazakhstan dated September 10, 2020 No. ҚR DSM-101/2020. The changes was adopted in the framework of harmonisation of national legislation with the requirements and rules of the EAEU. The order will be put into effect on September …