Servizi Regulatory Affairs

• Stesura documentale dossier CTD (m1, 2, 3, 4, 5)
• Due diligence dossier
• Regulatory Submission AIC in IT ed EU
• Life cycle management (variazioni AIC)
• Readability testing

Pharmacovigilance Services

• EU Qualified person/Deputy/ LPPV
• Screening della letteratura
• Stesura PSMF/ PSUR/DSUR/RMP
• Signal Detection
• Audit GVP

Regulatory compliance Integratori/Medical devices
Regulatory e PV Training