Pharmacovigilance

We offer personalized solutions to simplify pharmacovigilance in your company while ensuring safety. Our team of experts has extensive experience and can provide support tailored to your specific needs.

Set-up of PV-system

We offer our assistance in either the development of your entire PV-system or specific documents to meet your requirements. This will guarantee that all procedures and accountabilities are documented with strict quality control.

Risk Management Plan (RMP)

We help you create and implement an effective, resilient and proactive pharmacovigilance Risk Management Plan. Furthermore, we are happy to continuously review existing RMPs, monitor the implementation of RMP obligations and update the RMP accordingly in the case of new risks.

Summary of the Pharmacovigilance System Master File (PSMF)

The PSMF is a required tool for the overview of the PV-system. We help you to efficiently build up the necessary documentation and support you in implementing the requirements in your company. We prepare either a basic or a complete version, in which we also create the specific data of the attachments.

Reference Safety Information (RSI)

Our team assist you in preparing the Reference Safety Information (RSI), assessing Serious Adverse Reaction (SAR) and its expectability, as welll as meeting reporting requirements and adjusting the SmPC/ PIL based on the RSI.

Post Authorisation Safety Study (PASS) & Non-interventional Safety Study (NIS)

Post-authorization safety studies (PASS) play a crucial role in pharmacovigilance because they evaluate the safety and benefit-risk profile of medicinal products and support regulatory decisions. PASS can be conducted as interventional clinical trials or as observational studies (Non-interventional Safety Study, NIS). We can support you in planning, conducting, summarizing and submitting the PASS or NIS.

ISO IDMP standards (Identification of Medicinal Products)

Our services encompass the submission and maintenance of data to the data management services of SPOR in accordance with ISO IDMP standards. In addition, we take responsibility for submitting the prescribed data to the extended "EudraVigilance" database, also known as the "Article 57 database" or "xEVMPD".

‍Literature research

Saidia offers regular literature monitoring as part of your pharmacovigilance. We generate search strategies with high precision and summarize new, safety-relevant data from the globally available scientific and medical press as well as from regulatory authorities.

Periodic Safety Update Reports (PSUR)/ Periodic Benefit-Risk Evaluation Reports (PBRER)

Our services include the preparation of current PSURs/PBRERs on active substances with the aim of providing a comprehensive and critical analysis of the benefit-risk profile. New information is incorporated into a cumulative benefit-risk assessment. We offer the option of creating a purely literature-based PSUR or conducting an individual evaluation of company-specific data for a complete, submission-ready Individual-PSUR. Additionally, we are happy to handle the submission of safety reports to regulatory authorities, central ethics committees, and/or central institutional review boards, as well as to investigators on your behalf.

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