You want to develop the market; and you apply intelligent marketing strategies to achieve success with your prescription-only standard medicines and/or OTC products.

But you do not want to establish a unit of full-time staff for pharmacovigilance duties, because you cannot make full use of their capacity. We offer you the services necessary to meet the laws and ordinances.

We can write your patient information and prescribing information for you; we can review your promotional materials to ensure that they are factually correct and adjust these documents to take account of new requirements.

Under European and national law, every pharmaceutical company is obliged to nominate a person to be responsible for the safety of a medicine, the pharmacovigilance manager. This person monitors the product before and after marketing authorization is granted. He collects and evaluates all information of relevance to the safety of the medicine. It is particularly difficult for smaller companies to operate such a position and cope with the associated costs.

Choose from our wide range of services the one that suits your company’s needs.

This range includes the positions of the following persons as laid down in the German Medicines Act (AMG):

We can represent your interests on all drug safety issues before the Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) and other authorities. Reports received on adverse drug reactions (ADRs) are processed by us and passed on to the departments concerned within the required deadlines. We can also handle the electronic submission of ADR reports to the authorities, which is required by law as from 2005 (§ 63b AMG).

We can provide customized solutions for your company on a case-by-case basis as and when activities are actually needed.