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, readability testing
- Product evaluation and licensing consulting
- Consulting for clinical trials,
- Protocol development and
- Clinical master plan.