Regulatory intelligence
Regulatory insight for market entry, registration and lifecycle decisions.
Browse Pharegis guidance across medicinal product registration, APIs and CMC, GMP inspections, medical devices, clinical and preclinical development, variations and regulatory strategy.
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Selected regulatory guidance for market entry, approval and lifecycle decisions.
EAEU GMP inspection readiness for foreign manufacturers: preliminary audit, scope, dossier-to-floor review, interpreters, document translation, inspection, CAPA and lifecycle control.
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Pharegis regulatory guidance organised by practice area.
Drug registration in Russia under EAEU rules: pathway selection, CTD dossier, CMC, 3.2.P.5, GMP, samples, evidence, expert review and lifecycle strategy.
Post-2025 EAEU dossier alignment: pending transition cases, extended national authorizations, recognition states, dossier reconciliation, CMC, GMP and lifecycle strategy.
API registration in Russia for commercial active pharmaceutical ingredients: CMC review, GMP, ND, samples, standards, lab testing and lifecycle support.
EAEU medicinal-product variations under Decision 78 Appendix 19: IA, IA_NU, IB, II, extensions, grouping, recognition-state strategy and Russia-specific API changes.
EAEU Quality Document strategy: align the global CMC dossier, pharmacopoeial framework, expert laboratory assessment and lifecycle without unnecessary local technical complexity.
EAEU SmPC, patient leaflet and labeling: Decision 88/18, generic reference-product updates, 120-day lifecycle control, translation, variations and multi-state implementation.
When EAEU drug registration requires clinical or bioequivalence evidence: generic, hybrid, biowaiver, topical, biosimilar and foreign clinical-study strategy.
Russian clinical-study regulatory strategy: protocol, statistics, Investigator Brochure, informed consent, insurance, Ministry approval, CRO/site/bioanalytical-lab selection and logistics.
How foreign clinical studies can support EAEU registration: Decision 78 paragraph 36, local-study alternative, unscheduled GCP inspection, risk triggers, preparation and CAPA.
EAEU BCS biowaiver under Decision 85: Class I and III eligibility, reference product, solubility, excipients, dissolution, WHO/ICH screening and Pharegis feasibility assessment.
EAEU Module 4 preclinical evidence: when new studies are needed, foreign GLP data, generic vs original/hybrid strategy, nonclinical gap analysis and GLP inspection risk.
EAEU biological and biosimilar preclinical strategy: Decision 89, comparability, relevant species, in-vivo studies, immunogenicity, GLP and Module 4 inspection readiness.
