About us

History

HORN Pharmaceutical Consulting was established in 2002 by Dr. Hiltrud Horn. The company is located in the centre of the baroque city Bruchsal, Baden-Württemberg, Germany.

Team

Our team consists of internationally experienced specialists with detailed know-how in the planning and preparation of regulatory documents. Working in an environment of mutual support and cooperation, our employees share a passion for excellence and leadership. Everybody at HORN Pharmaceutical Consulting is committed to achieve valuable solutions for our customers. We evaluate potential regulatory scenarios and recommend you which way to go in order to achieve long-lasting results.

Dr. Hiltrud Horn

Dr. Hiltrud Horn, the founder of HORN Pharmaceutical Consulting, has more than 25 years of experience in the pharmaceutical and biotechnology industry. She is regularly invited as speaker at conferences, workshops and seminars on the development and registration of new chemical entities and biotech products. Dr. Horn has successfully developed her activities in the field of
  • International regulatory affairs
  • Project management
  • Drug product development
  • Quality/Chemistry, Manufacturing and Controls (CMC)
  • Quality Assurance (QA) 
  • Medical writing
  • Good Manufacturing Practice (GMP)
  • Good Clinical Practice (GCP)
  • Good Laboratory Practice (GLP)
  • Preparation and submission of dossiers for clinical trials and for marketing authorisation
  • Post-marketing activities (changes and renewals)
After her graduation as a pharmacist from the University of Tuebingen in Germany she completed her studies with a PhD in Human Biology at the University of Ulm. Furthermore she holds an ECPM-Diploma (Diploma in Pharmaceutical Medicine) from the Eucor University of Basel. She has an additional qualification as pharmaceutical expert for drug information (Fachapotheker für Arzneimittelinformation) and as pharmaceutical expert for pharmaceutical analytics (Fachapotheker für pharmazeutische Analytik).

Prior to establishing HORN Pharmaceutical Consulting, Dr. Horn had been in various managerial positions in pharmaceutical industry at F. Hoffman-La Roche in Basel (Switzerland), BASF Pharma, Knoll AG (later Abbott) with responsibilities for the development and registration of new drugs in Europe and US. Her activities were in the field of international regulatory affairs, project management, quality control, quality assurance, preparation of dossiers (quality part and clinical part), dossier compilation and submission. Furthermore she worked as consultant for the biotech industry at Cap Gemini Ernst & Young Deutschland GmbH.

At the end of 2002, Dr. Hiltrud Horn decided to start her own business and became an independent consultant.

Dr. Horn professional affiliations are:
  • Deutsche Gesellschaft für Regulatory Affairs (DGRA)
  • Drug Information Association (DIA)
  • Deutsche Gesellschaft für Pharmazeutische Medizin e.V (DGPharMed)
  • Parenteral Drug Association (PDA)

HOTLINE

Phone +49 (0) 7251/305 529
Fax +49 (0) 7251/305 528
Mail

Events

  • 08.05.2019
    Mannheim: Aktuelle Trends in der Qualitätskontrolle
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  • 14.-15.04.2019
    Cologne: Der Regulatory Affairs Manager
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  • 16.-17.05.2019
    Vienna: Annex 2 & Co - GMP Compliance for Biopharmaceuticals
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News

  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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