According to the new guideline for Good Pharmacovigilance Practice (GVP), every manufacturer of pharmaceuticals has to have a pharmacovigilance system (PV system) in place. The quintessence of the system is built by qualified experts, who have to be available at all times. To cover this a complex organisation has to be provided.

PV-experts, especially physicians, are rare and expensive. Manufacturer of genetic pharmaceuticals are threatened through disproportionate high costs, respectively risks through audits by regulatory authorities.

In this situation outsourcing is advantageous to binding of own expensive resources. Because all PV processes are regulated through guidelines in detail, a qualified, external service provider complies them without trade-off.

medwiss-extern offers you security through qualified, experienced experts. You only have to pay the actual costs, resulting from your product portfolio. This allows you to present a complete, audit-conform PV system to regulatory authorities for a fraction of the costs and you can focus on marketing of your products.

medwiss-extern offers the following PV-services, which can be supplied separately or in total:

• Responsibility compliance of the Stufenplanbeauftragten acc. to § 63a AMG

• Compilation, adaptation and maintenance of the Pharmacovigilance Master File (PSMF) and all associated SOPs

• Periodic Safety Update Reports (PSUR)

• Risk Management Plans (RMP)

• Clinical Expert Statements (CES)

• Recording, processing and reporting of adverse drug reactions (ADR)

• Staff training according to GVP

• Literature research

• Correspondence with regulatory authorities

• Telephone service on standby

Of course all documents can be generated in German and / or English language.

Send a request and you will be positively caught by our favorable prices.