By combining my main competencies I create holistic solutions for start-ups and pharmaceutical companies in times of change.
Life cycle management starting from project management during drug development up to QP release of narcotics, e.g. Cannabis.
Creative solutions throughout different marketabilities – OTC medicines, food supplements, cosmetics and medical devices.
25+ years of experience with phytomedicines – marketing authorizations, manufacture and testing.
Concepts, building and establishing of GxP related quality management systems (manuals, SMF, SOPs etc.), interim management.
Building structures for the realization of new medicines – CRO, drug formulation, CMO and laboratory testing.
Individually or third party audits – Germany-, EU- or worldwide.
Consultancy and concepts for new companies (start-ups) or for building new business segments.
Having an ear for the market – excellent network for the sourcing of licenses.
Everything around CTD module 3 – Preparing data from manufacture and testing, incl. stability testing ready for submission. AMRadV applications (Germany) for Cannabis.