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
The Russian side opposed to postpone Implementation period of the EAEU Rules of marketing authorisation
21.11.2020 The Ministry of Economic Development of the Russian Federation, as a representative of the Russian side, sent an official letter to the EEC to object to the decision to prolong transition period. The transition period of the Rules of marketing authorization supposed to be extended until the 31st of December, 2022, as announced at the meeting of the EEC Working Group on Medicines on the 05.10.2020 – 07.10.2020. …
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 …