Your key to successfully setting up a pharmacovigilance system

Expert Advise | Strategic outsourcing | Business process management | Customized solutions

More than 10 years of experience in clinical research and drug safety, in-depth experience in overcoming the challenges faced by a pharmaceutical or biotech company in setting up and developing its pharmacovigilance system. Expertise in business process management, integration of a PV system according to M&A as well as consulting and project management

Pharmacovigilance Vendor Management


Strategyic Outsourcing

The delegation of GvP tasks to service providers in the outsourcing process requires a high degree of organization and monitoring in order to comply with regulatory standards and to maintain sovereignty over its activities as a company. In the area of pharmacovigilance, this applies in particular to the reporting of adverse drug reaction reports. Quality, compliance and efficiency are ensured by strategically designing the outsourcing process and monitoring the service providers.

PV Partner Management

The implementation of license agreements in the context of PV partner management regularly generates complex regulatory responsibilities that must be fulfilled in the form of contracts (SDEA, PVA) and delegations. The implementation of contracts with regard to obligations of marketing authorization holders (MAH) must be carried out systematically and efficiently.

Organisational Assessment

When an organization is growing or is facing new challenges, a systematic assessment of the structures is a helpful means of identifying potential for improvement and reducing regulatory risks. An external perspective can help here.

Business Process Management

The sensible organization of all PV business processes presents many fast-growing companies with many challenges. Automating manual activities and introducing validated systems is a key task for modern pharmaceutical and biotech companies. We help them to select and implement the right systems and ensure that a bad analog process does not become a bad digital process.


Daniel Regut

"I have worked together with Stefan over several years and have gotten to know him as a highly motivated professional, with whom it's a pleasure to work with. Not only a cooperative and pleasant spirit, but a person with a highly analytical, sharp mind who gets to the root of problems, finds solutions and has the ability to take the team with him while striving for and implementing solutions."

Daniel Regut
Sr. Clinical Research Associate & CRA Trainer

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