Regulatory affairs
Pharmacovigilance
GxP compliance
Training courses
Market access
Medicines
(NP, DCP, MRP – EAEU/EU)
Determination of
regulatory strategy
Preparation of the dossier
Submission and communication with the Competent authority
Medical Devices
(EU/EAEU/CIS)
GAP analysis of
Technical file
Preparation of a
Technical file
Certification of the
medical devices
Food Supplements
(EU/EAEU/CIS)
Preparation of documents
(according to the relevant national requirements)
Submission and accompaniment of the procedure
Cosmetics
(EU/EAEU/CIS)
Preparation of
Cosmetic product file
Submission and accompaniment of the
procedure
EU QPPV and
EAEU QPPV services
Local contact Person on Pharmacovigilance issues (LPPV)
Global and local literature monitoring
Case Processing and
Reporting
Development of a
Risk Management
Plans (RMP)
Aggregate Reports
(DSUR/PSUR)
PV system auditing
Inspection readiness
Preparation of
PSMF and SOPs
GMP
pre-certification audit
CAPA preparation and implementation support
Organisation of official inspections
Development of quality assurance documentation
Market overview
and trend analysis
Market access
strategy report
Marketing and
promotion of products
Distribution on EAEU,
CIS and EU markets
Topical
seminars
Practical
workshops
Customised
on site trainings
Interactive
webinars