Building a Pharmacovigilance SOP system
We help you set up and implement a structured quality management system that meets both legal requirements and your individual needs.
RMP (Risk Management Plan)
We prepare risk management plans according to GVP module V for your new submission. Contact us for an offer tailored to your product.
Pharmacovigilance System Master File (PSMF) and Summary of Pharmacovigilance
We support you in the creation of the PSMF. Of course, this also applies to an update of an existing DDPS.
Reference Safety Information (RSS and CSS)
Our team, experienced in medical writing, will assist you in writing the Reference Safety Information.
PASS and NIS
Do you need support in the preparation and management of post-marketing studies? Then contact us for a solution tailored to your product.
We take care of your XEVMPD entries and updates and prepare you for the ISO IDMP standards.