Pharmacovigilance and information control are central tasks of a Marketing Authorisation Holder (MAH). Regulatory authorities demand qualified and experienced specialists to fulfil these functions. QPPVs (Stufenplanbeauftragte) and information officers are personally responsible for compliance with relevant obligations. In case of infringement to the more and more complex growing regulations severe sanctions are imminent.

Qualified, experienced specialists are rare on the job market and expensive. Respective input and actually necessary resources are often disproportionate, especially in marketing generic products.

In this situation outsourcing is a secure and cost-efficient solution for a lot of manufacturers for three good reasons:

• Security, that all obligations are audit-conform and met according to regulatory authorities

• Savings, because costs are usually clearly reduced than with own staff

• Efficiency, because digital communication guarantees reliable and fast exchange of data with an external service provider

medwiss-extern service offering

Service with expert knowledge and experience at a reasonable price for the following divisions:

• Pharmacovigilance and Stufenplanbeauftragter according to AMG § 63a

• Information officer according to AMG § 74a

• Medical-scientific consulting

• Medical writing

• Staff training through e-learning on basis of moodle
  

Contact us and assure yourself of our professional competence and our favorable conditions. We gladly convey contact to referencing customers, who can provide relevant information about us.