Alexander Henke - RA-Consulting

Alexander Henke - Regulatory Affairs Consulting

National, European & Global

Regulatory Affairs – Support the way for success

From Product Development to a Registered Drug

Due diligence for product acquisitions
Support in preparation and filing of new registrations and maintenance changes
Support in preparation on national or international scientific advice filings
Build-up of reporting structure and tools

Support in implementing of RIM system
Support in implementing of IDMP relevant systems and adapting running tools
Support in building-up of new structures within RA-frame and cross-functional
Support in bridging RA needs with GxP requirements (GMP & GDP)

Review of internal processes
Process-Analytics
Definition of Improvements
Implementation of adapted processes
Definition & implementation of KPIs
Definition & implementation of review tools and cycles

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Alexander Henke - RA-Consulting
Mittlerer Weg 19

86441 Zusmarshausen (Germany)

Phone: +49-152 25218646

mail: henke.ra-consulting@magenta.de

Steuernummer: 102 227 72716

VAT-no: DE341784046

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