spmd offers custom safety solutions to meet your specific company needs…
We offer services as your full service external (pharmaco-) vigilance department or modular project specific services. We have experience with all company sizes, from small start-ups to multi-billion-dollar companies. It is worthwhile to compare our services with in-house solutions.
Services
Our professional experience includes:
Global Development
Managing global development projects resulting in successful marketing authorization
Quality Management
Implementation of SOP and Quality Management Systems
E2B Compilant-Database
Implementation and validation of E2B-compliant (pharmaco-) vigilance databases
Information Service
Data management including migration of safety data Systems
Plans & Reports
Generation of Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs) and Risk Management Plans (RMPs)
Safety Departments
Managing global drug safety departments
QP-Pharmacovigilance
Acting as QP Pharmacovigilance (EU-QPPV)
Risk management
Generation and implementation of risk management procedures.
