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.


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


Acting as QP Pharmacovigilance (EU-QPPV)

Risk management

Generation and implementation of risk management procedures.

Our exclusive cooperation

++ Through our exclusive cooperation with spm², a specialized European safety service provider, spmd can offer a E2B compliant safety database and additional professional expertise in the complex regulatory environment of Europe à please visit spm² ++