Our Services
GxPLine offers expert consulting in GxP, Regulatory and Clinical fields
GMP Service
Assistance in Quality System development & Documentation writing
Practical assistance in core QMS elements - CAPA, deviations, temporary changes, risk assessments etc.
GMP audits, pre-audit for EMA, WHO, EAEU inspections, support during inspections, support in CAPA plans development
Assistance for validation strategy, validation documentation, methodology, icl. process validation, cleaning validation etc.
GMP training: general and specialized themes
Regulatory Service
Regulatory strategy
Dossier documentation development (CMC & others)
Dossier gap analysis
Expert support on responses to Deficiency Letters
Clinical Service
Full support for the clinical development of generic formulation through established collaboration with international ioequivalence centers
Documentation writing
Contact us
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