On your behalf, we can take over and fulfil your duties in all matters of drug safety vis-à-vis the Federal Institute for Drugs and Medical Services (BfArM) and other authorities. This comprises all work for the weekly research up to tasking over the activity of the appointed persons (graduated plan officer, EU-QPPV). Not every company requires support in all fields of activity. In direct consultation with you, we will offer you a specially-tailored catalogue of services for the field of drug safety.
Overview of services
Setting up a pharmacovigilance system
Production of a “Pharmacovigilance System Master File (PSMF)”
Weekly literature research
Analysis and processing of the “Medical Literature Monitoring (MLM)” of the EMA
Carrying out of signal detections
Analysis of PV-relevant publications (e.g. study reports)
Writing of “Periodic Safety Update Reports (PSURs)” and/or “Periodic Benefit-Risk Evaluation Reports (PBRERs)”
Production of “risk management plans (RMPs)”
Input and maintenance of “EudraVigilance Me-dicinal Product Diary (xEVMPD)” data
For us, the submission of a PSUR is part of PSUR processing.
Our range of services comprises the assigning of legally specified persons in accordance with the AMG, AMWHV and EU law. This includes the information officer (§ 74a AMG), phased plan officer (§ 63a AMG) and EU QPPV.
Graduated plan officer (Section 63a AMG [German Medicinal Products Act])
According to the German Medicinal Products Act, every pharmaceutical entrepreneur (pU) must have a PV system, for which the graduated plan officer is responsible. In addition to this, the graduated plan officer gathers and analyses all reports about risks of medicines (including deficiencies in quality) and coordinates the necessary measures. A benefit-risk profile is to be produced as a result of this procedure and updated on an ongoing basis.
QPPV in accordance with "Article 104 (3)(a) of Directive 2001/83/EC"
A QPPV is required for medicinal product marketing authorisation outside Germany in the EU. This abbreviation refers to a pharmacovigilance officer (Qualified Person Responsible For Pharmacovigilance) who – unlike the graduated plan officer in Germany – is not responsible for the processing of quality defects. At EU level, the QP (qualified person) is responsible for any quality defects.
Information officer (Section 74a AMG)
The information officer is to ensure that “the labelling, the package leaflets, the expert information and the advertisements correspond with the content of the marketing authorisation or registration” (Section 74a (1) AMG ). The information officer checks the informative texts (package leaflet, expert information etc.), advertising texts and advertisements for their conformity with the marketing authorisation documents.
Provision of PV SOP system
As a pharmaceutical company we maintain an SOP system for the entire field of pharmacovigilance. We offer you the option of referring to our system instead of having to spend a lot of time and resources on implementing and maintaining a new system.
Thanks to the maintaining of our system you will also always be up to date.
Checking of informative texts
For us, the checking of informative texts, incl. for the printing of package leaflet information, for commercial purposes, etc., is part of pharmacovigilance. Because in our view information texts have an important influence on drug safety. Incorrect texts can have a negative effect upon this. Our trained and experienced employees check your texts carefully and promptly. Especially when the launching of a product depends on the approval of the informative texts, we divide our time up flexibly, in order to prevent any delay arising in your plans.
We take over the task of pharmacovigilance in all phases of clinical trials. We are familiar with the special features of this subdomain of drug safety from many projects.
Our range of services also includes other aspects of clinical research. Talk to us – we will be happy to help – or find out about this subject in more detail on our sites on Clinical Trials.
Readability tests for pharmaceuticals and medical devices
Adaptation of your package information leaflet to the current QRD guidelines
Optimisation of the layout
Optimisation of linguistic style through the application of linguistic criteria for readability and comprehensibility
Development of a product-specific questionnaire
Recruitment of probands (native speakers!)
Conducting of individual interviews with 20 probands
Analysis and production of the test report (in English)
Depending on your requirements, we also conduct proband tests with native speakers in other languages such as e.g. in English, French or Dutch.
We produce the tests for fixed prices!
Drug safety for veterinary pharmaceuticals
The new regulatory requirements are necessitating a greater and greater degree of indepth knowledge and expertise for veterinary drug safety too. Instead of you having to laboriously build up this knowledge, we can help you to meet all the requirements quickly and in a target-oriented way. Of course, as a specialist company, our team also includes a veterinarian who evaluates and classifies facts from daily practice.
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Mo-Fr: 8:30 a.m. – 1:00 p.m.
Mo-Fr: 2:00 p.m. – 4:30 p.m.
+49 (2821) 7277-0