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.

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 ++