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EU compliant system
Vol.9 Risk Managem. Plans
SOP Development
Qualified Person (QP)
E2B compliant database
SUSAR/ICSR Management
Data entry
Literature Search
& more ...
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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.