BIOGRAPHY

Professional Biography


Dr Joanne Hart

  • 20+ years in the pharmaceutical sector

  • 15+ years in the regulation of medicines

  • 8 years in R & D

  • Ph.D. in Chemistry

  • Grad. Dipl. in Toxicology

  • Member of DGRA

Dr Joanne Hart is the founder of KORU Pharma Solutions GmbH, a German-registered company head-quartered in Frankfurt, Germany.

Dr Hart is a regulatory affairs expert with an educational background in chemistry and toxicology. She specialises in regulatory CMC, specifically in Module 3 of the CTD dossier.

Dr Hart started her career in the field of drug development and her publications reflect a diverse range of research interests including anti-cancer drugs, analytical chemistry, diabetes  and carbohydrate chemistry.

A subsequent transition into a medicines regulatory authority provided broad understanding  of, and practical experience in, the regulation of medicines - from the regulator’s perspective. During this time Dr Hart worked in various departments on a range of different regulatory projects, culminating in a branch manager role and staff management.

 
A relocation to Germany provided the opportunity to set up as an independent consultant specializing in regulatory CMC
— Dr Joanne Hart
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Dr Joanne Hart


Email Dr Joanne Hart today and discuss your regulatory CMC and lifecycle management needs.

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A relocation to Germany provided the opportunity to set up as an independent consultant specializing in regulatory CMC. Dr Hart initially provided pharmaceutical chemistry assessment services to regulatory authorities including TGA and WHO. Now offering services exclusively to industry, her clients to date include both major and medium-sized international pharmaceutical companies.

Dr Hart speaks English (native speaker) and German.


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