Signifix
Services
Signifix is a boutique consultancy company focused on global access for innovative medical devices, human tissue allografts and cell therapies
Medical Devices
Market approval processes including EU MDR – CE certifications – US FDA clinical trial and US device approvals. Implementation of ISO 13485 quality management systems.
Human Tissues
Tissue establishment licensing services including responsible person activities. Regulatory and quality processes towards market approvals, market access in both EU and US.
Cell Therapy and Biologics
Regulatory and quality processes towards clinical trial readiness, marketing authorization (EMA), biological license application (FDA), GDP activities.
Get in touch
Contact us
Contact
Jeroen Pieper
+31 (0)6 1146 1426
Richard van der Linden
+31 (0)6 2862 2870
Office
+31 (0)30 229 72 10
Email: info@signifix.com
Signifix BV
Professor Bronkhorstlaan 10
Building 86
3723 MB Bilthoven
The Netherlands
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