It’s all about quality

By combining my main competencies I create holistic solutions for start-ups and pharmaceutical companies in times of change.

My areas of focus

  • Rx / medicines

    Life cycle management starting from project management during drug development up to QP release of narcotics, e.g. Cannabis.

  • OTC / healthcare

    Creative solutions throughout different marketabilities – OTC medicines, food supplements, cosmetics and medical devices.

  • Herbal medicines

    25+ years of experience with phytomedicines – marketing authorizations, manufacture and testing.

  • Quality

    Concepts, building and establishing of GxP related quality management systems (manuals, SMF, SOPs etc.), interim management.

  • Research and development

    Building structures for the realization of new medicines – CRO, drug formulation, CMO and laboratory testing.

  • Audits (GMP, GDP)

    Individually or third party audits – Germany-, EU- or worldwide.

  • Market access

    Consultancy and concepts for new companies (start-ups) or for building new business segments.

  • Licenses / products

    Having an ear for the market – excellent network for the sourcing of licenses.

  • Marketing authorization / CMC

    Everything around CTD module 3 – Preparing data from manufacture and testing, incl. stability testing ready for submission. AMRadV applications (Germany) for Cannabis.