ML PV & Medical Writing Consulting provides comprehensive pharmacovigilance support for marketed medicinal products, early or compassionate access programs, and products in clinical development. Our services are tailored to meet French and European regulatory requirements while ensuring patient safety and regulatory compliance.
Our services
- Pharmacovigilance legislation monitoring at both the French and European levels
- Medical literature monitoring
- Preparation, writing, and submission of Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).
- Writing, implementation, and maintenance of the EU Pharmacovigilance System Master File (EU PSMF) and the French Local PSMF.
- Signal detection, validation, assessment, and management throughout the product lifecycle.
- Processing and reporting of Individual Case Safety Reports (ICSRs) and Suspected Unexpected Serious Adverse Reactions (SUSARs), including MedDRA coding and submission to the appropriate competent authorities.
- Management of competent authority safety requests, ensuring accurate and timely responses.
ML PV and Medical Writing Consulting 