Lifecycle Management Support For Veterinary Vaccines And Pharmaceuticals
Geographical and line extensions
Regulatory defence strategies
Dossier compilation, revision
Critical summaries and expert statements
Planning, managing procedures
Marketing support

Regulatory Issue Resolution
Crisis and issue management
Expert resource support
Problem analysis and strategic plans

Pharmacovigilance
QPPV
Adverse Event investigation & reporting
Periodic Safety Update Reports
PV Data resource optimisation

SPC and labelling
Business-positive SPC phrasing
Multi-country packaging

Regulatory Intelligence
European and National regulatory environments
Competitor regulatory activities
Public information research and analysis
Regular reports

Borderline Products
Veterinary Product, Biocide, Food or Feed Additive?

Contact ASSENTRA Ltd. for further information and to discuss your needs.