Services for pharmaceutical
and health care companies

Dr. Kerstin Thaele

I offer your company professional support based on many years of international experience in pharmaceutical industry.

Professional Services

  • GMP consulting, auditing
  • Qualified person (German drug law 19)
  • Interimsmanagement (research and development, quality management)
  • Preparation of quality documentation and expert reports
    (modul 2.3 and modul 3)
  • Project management, R&D projects
  • Process analysis, quality management, auditing (DIN EN ISO 9001)

Services for small and start up pharmaceutical companies

  • Preparation of Investigational Medicinal Product Dossiers (IMPD)
  • Solutions for preparation and release of clinical supplies
  • Qualified person (German drug law 19)
  • Conception of  IT infrastructure together with cooperation partner Metaways Infosystems GmbH

Please contact me!

More Links:

thaele-pharma.de
Metaways Infosystems GmbH

European Medicines Agency Home

ema.europa.eu

European Medicine Agency 

zlg.de

The Pharmaceutical Inspection Cooperation Scheme – PIC/S

picscheme.org

EudraCT Home page – Community Clinical Trial system

eudract.ema.europa.eu

Food and Drug Administration Home Page

fda.gov

European Commission – Enterprise and Industry – Pharmaceuticals

ec.europa.eu

+49(0)4532 - 288 07 99

+49(0)151 - 17 54 38 68

Dr. Kerstin Thaele

Schloßstr. 49
22967 Tremsbüttel
Germany