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SERVICES
… we are here to help.
Any resource or support you need can be handled by our highly dedicated, professional and experienced (pharmaco)vigilance team.
Our processes are fully compliant with local and international regulations and guidelines, and we work with a fully validated, ICH E2B(R3) and FDA 21 CFR Part 11 compliant safety database.
Besides many national Marketing Authorization Applications (MAAs), we have successfully supported multiple dual EU/US MAAs.
SERVICES
We offer full (pharmaco-)vigilance service level support throughout the lifecycle of your product
… we are here to help.
Any resource or support you need can be handled by our highly dedicated, professional and experienced (pharmaco-)vigilance team.
Our processes are fully compliant with local and international regulations and guidelines, and we work with a fully validated, ICH E2B(R3) and FDA 21 CFR Part 11 compliant safety database.
Besides many national Marketing Authorization Applications (MAAs), we have successfully supported multiple dual EU/US MAAs.
spm² offers pre- and post-marketing vigilance services to pharmaceutical and medical device companies, as well as to the cosmetics industry.
Moreover, we support academic institutions, federal agencies, and non-profit organizations.
Our clients consist of start-up enterprises as well as multi-billion-dollar global companies.
WE COVER
We offer full (pharmaco-)vigilance service level support throughout the lifecycle of your product
INSPIRED BY SAFETY!
Welcome at spm² – safety projects & more GmbH
Explore the world of (pharmaco-)vigilance and how we can support you…
spm² – safety projects & more GmbH
Goldbeckstraße 5,
69493 Hirschberg an der Bergstraße
Phone: +49 (0) 6201 – 846 40-0
Email: info@spm2-safety.com