Clear regulatory answers
Complex markets.
Senior regulatory control.
Senior regulatory support for medicinal product registration, lifecycle management, GMP inspections, medical devices, clinical development and regulatory strategy across Russia, the EAEU, CIS and selected GCC markets.
Expertise
Six practice areas.
One regulatory operating model.
Integrated regulatory support across the workstreams that determine market entry, approval and lifecycle continuity.
Medicinal Products & Lifecycle
EAEU medicinal product registration, API registration in Russia, dossier harmonisation and variations.
02
GMP & Inspections
EAEU GMP certification, inspection readiness, documentation, CAPA and authority expectations.
03
Medical Devices
Registration, technical documentation, clinical evidence and certification questions.
04
Clinical & Preclinical Studies
Clinical and preclinical evidence programmes supporting medicinal product registration.
05
Pharmacovigilance
EAEU pharmacovigilance systems, PSMF and RMP governance, local vendors and sponsor oversight.
06
Regulatory Consulting
Pathway assessment, gap analysis, regulatory strategy and decision-ready planning.
Why Pharegis
Senior regulatory support
without the hand-off chain.
Credibility is built through controlled scope, traceable regulatory reasoning and direct senior involvement — not decorative metrics.
Complex regulatory decisions remain close to senior specialists.
Technical guidance is separated from marketing language and reviewed against the applicable regulatory context.
Registration, variations, inspections and post-approval commitments are treated as connected workstreams.
Regional Gateway
Regulatory pathways
across complex markets.
Insights
Selected technical
regulatory articles.
Selected guidance on registration, GMP, lifecycle management, clinical development and medical devices.
Confidential enquiry
Discuss a regulatory project.
Tell us the product, jurisdiction and current regulatory stage. A senior specialist can review the context before the first discussion.