Services

++ Please note: this website is still under construction ++

spmd is a service provider founded in 2016 in the USA, offering state of the art (pharmaco-) vigilance services for the pharmaceutical industry.
The founders of spmd have a long standing international experience in clinical development, clinical pharmaceutical research and (pharmaco-) vigilance particularly in Europe and the USA.

Our professional experience includes:

  • managing global development projects resulting in successful marketing authorization
  • implementation of SOP and Quality Management Systems
  • implementation and validation of E2B-compliant (pharmaco-) vigilance databases
  • data management including migration of safety data
  • generation of Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs) and Risk Management Plans (RMPs)
  • provision of drug information services
  • managing global drug safety departments
  • acting as QP Pharmacovigilance (EU-QPPV)
  • conduct of risk management procedures

We strongly believe that (pharmaco-) vigilance 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 safety solutions either as your full service external (pharmaco-) vigilance department or modular project specific services.
It is worthwhile to compare our services with in-house solutions, especially as a mid size company with limited case volume.


++ 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 please visit spm² ++