spm² is a service provider founded in 2005, offering state of the art pharmacovigilance services for the pharmaceutical industry.

spm² is dedicated to the following core values :

• Regulatory Compliance
• Responsibility and accountability in managing safety for our clients
• Professional pharmacovigilance and quality management
• Medical Scientific Excellence
• Value based safety management

spm² was founded by physicians, IT-specialists and business executives with long standing experience in the pharmaceutical industry, particularly in the area of pharmacovigilance in Europe and the USA.

Our professional experience includes:

• managing as head of global drug safety departments

• acting as QP Pharmacovigilance/"Stufenplanbeauftragter" according to the German Drug Law

• conduct of risk management procedures

• implementation of SOP and Quality Management Systems

• generation of PSUR and risk management plans

• implementation and validation of E2B-compliant pharmacovigilance databases

We strongly believe that pharmacovigilance management not only is essential for patient’s safety but also is value adding to the company’s pharmaceutical product portfolio.

We offer tailor-made drug safety solutions either as your full service external pharmacovigilance department or modular project specific services.

It is worthwile to compare our services with inhouse solutions, especially as a mid size company with limited case volume.

However, we have experiences and offer services beyond pharmacovigilance.

" & more ... " is our mission.

Other services include:

• Labelling
• Product evaluation and licensing consulting
• Consulting for clinical trials,
• Protocol development and
• Clinical master plan.