Audit Consultancy
Clinical Trial PV Services
Medical Information Consultancy
Medical Information Contractor
Medical Writer
Out of Hours Services - MI
Out of Hours Services - PV
Pharmacovigilance Consultancy
Pharmacovigilance Contractor
Promotional Compliance Consultancy
PSUR Writer
QPPV Consultancy
Signal Detection Consultancy
Trainer
With 31 years of global experience in:
Pharmacovigilance – Auditing & Inspection Preparation incl. QMS and KPI assessments; PSUR/DSUR/PBRER/PADER writing; Signal Detection; SOP writing; RMP/REMs; Safety Database selection and validation; Literature searching and reviews; Training; Writing safety sections for IB/Protocols/SAE design; DCSI/CCSI development and maintenance; Benefit-Risk assessments; PSMF writing and maintenance.
Medical Affairs – FAQ writing; Promotional sign off; Answering medical enquiries; training; Competitor analyses; medical information database design; Auditing; SOP writing.
