We earn the loyalty of our customers by delivering high quality documents, on-time results, and viable solutions and excellent regulatory services that ensure their satisfaction.

Large Companies and Industries

Our clients range from small, mid-size businesses to large multinational companies. Since 2002 we have worked successfully with over fifty different pharmaceutical and biotechnology companies including Active Pharmaceutical Ingredient (API) manufacturers and venture capitalists.
We have assisted companies from Europe and USA in all stages of drug development to get and keep their products on the market and to successfully meet the challenges of the regulatory agencies (EMA, FDA, national).


Small and Medium-sized Enterprises (SMEs)

Micro, Small and Medium-sized Enterprises (SMEs) are the engine of the European economy. However, they are often confronted with market imperfections. SMEs frequently have difficulties in obtaining capital or credit, particularly in the early start-up phase. Their restricted resources may also reduce access to new technologies or innovation.
Therefore, support for SMEs is one of HORN Pharmaceutical Consulting priorities.
We lead our SME clients through the regulatory jungle by providing the following services:
  • Regulatory consulting
  • Business consulting
  • Customer relationship management consulting
  • Administrative and procedural issues advice
  • Project management
  • Specifically tailored in-house trainings
  • Scientific evaluation of quality and non-clinical data during drug development
  • Auditing
  • Design of clinical trials
  • Finding cooperation partners



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


  • 13.-14.07.2020
    Live Online Seminar: Der Regulatory Affairs Manager
  • 25.08.2020
    Frankfurt: Prozessvalidierung - Aktuelle Anforderungen an CMC-Daten
  • 06.-07.10.2020
    Vienna: Change Control – New Aspects and Best Practices
Get all events


  • 18.05.2020
    Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
  • 26.03.2020
    New Deadline for Nitrosamine Impurities
  • 24.03.2020
    News on Nitrosamine Impurities
Get all news
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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