Our securities must not become rigid, or they will break.

Robert Walser

Despite extensive studies, not all safety aspects are known at the time of first authorisation of medicinal products. New findings can also emerge long after medicinal products have been approved. For this reason, the European Medicines Agency requires the marketing authorisation holders to collect and evaluate experience with the use of a medicinal product on an ongoing basis.

We offer you a complete pharmacovigilance system. Alternatively, you can book the components that apply to you individually. With these tailor-made solutions you can meet the legal requirements.

Our range of services includes:

Qualified Person for Pharmacovigilance (QPPV)/ Graduated plan officer

The Qualified Person for Pharmacovigilance (QPPV) ensures a functioning pharmacovigilance system. He or she regularly monitors and controls the training of your employees and checks if all the PV-relevant documents are up-to-date. You, as the marketing authorisation holder, will be informed by the QPPV about the safety of your medicines. Dr. Jeanette Haney will be happy to take responsibility for the safety of your medicines, be they national authorisations or European authorisations (CP, MRP, DCP).

PSMF (Pharmacovigilance System Master File)

The Pharmacovigilance System Master File is a living document describing your company-specific PV system for all your medicinal products. After creation, a regular update is necessary to maintain the continuous safety of your medicinal products.

SOPs (Standard Operating Procedures)

All processes that affect the safety of your medicinal products are strictly regulated by law. Corresponding SOPs cover these areas. We offer SOP packages that can be implemented in your SOP system. All processes are tailored to your company structure. This means that you only receive the SOPs that you need and according to which you can work.

Literature search

Drugs from SMALL pharmaceutical companies are often genuine “specialties” and have a unique position on the market. Therefore, they are not covered by the literature monitoring of the EMA (so-called MLM service). We will do the search for information on the safety of your active substances in the scientific literature.  Thanks to our well-structured internal processes, we are able to cover these requirements in the best possible way, ensuring continuous monitoring and an optimal flow of information.

PSUR (Periodic safety update report)

Our internal processes remind us regularly when a PSUR has to be written. We are therefore able to submit all applications on time, without any pressure of time. You are welcome to write your own PSUR and send it to us. In this case, we merely take over the electronic submission, as required by law.

Safety reporting

We are prepared to write ICSRs and submit them to the European Medicines Agency (EMA). Our employees are continuously trained in the use of the special software and we make sure that any information required will be forwarded to the EMA or other competent national authority promptly and on time.

RMP, SPC, PIL

Risk management plans reflect the benefits of your medicines. They show which measures can be taken to minimise risks. They also reflect research findings for their benefit and risk. This document must also be checked regularly for correct content. This includes, for example, the adaptation of data on side effects or the integration of further clinical studies.

We implement changes that are indicated by the authorities or the PRAC for user and technical information and adapt the RMP accordingly.

xEVMPD

The eXtended Eudravigilance Medicinal Product Dictionary maps all medicinal products with the most important information and is mandatory for you. With our own software, we feed all your products with their respective approval holder, status of the approval and further data into the EMA system.

If you are interested in a personal offer, please contact our pharmacovigilance team here. We will be happy to advise you.

This post is also available in: German