Drug Substances

The role of Active Pharmaceutical Ingredient (API) manufacturers is rapidly changing. As the pharmaceutical industry evolves the most successful API manufacturers will be those that are able to quickly adapt to industry needs and global pressures. HORN Pharmaceutical Consulting can not only help you to adjust to the global demands, but with our comprehensive API services you will be able to stay ahead in this rapidly growing industry.

With us you will maximize your success in drug substance development. Our specialists will help you to understand the important characteristics of your Active Pharmaceutical Ingredient (API), its control in manufacturing and release as well as its consistent production. We have solid in-depth knowledge of the EMA and FDA regulations and ICH guidelines which will hep you determine the specifications for Active Pharmaceutical Ingredients (APIs), raw materials, intermediates, drug products and excipients to ensure that they comply with the respective Pharmacopoeias and regulatory requirements.


We are offering the following services in the API area:
  • Regulatory filings in Europe and US, ranging from IMPD/IND to MAA/NDA-submissions
    • Preparation and submission of:
      • Drug substance part of the CTD
      • Certificate of suitability (CEP)
      • European Drug Master File (ASMF)
      • US Drug Master File (DMF)
  • Preparing GMP systems for APIs for clinical use and for commercial production
  • General analytical testing
  • Analytical validation
  • Process validation
  • Method development
  • Stability testing programs
  • Regulatory affairs
  • Quality assurance


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


  • 28.-29.09.2021
    Live Online Training: Product Transfer - Organisation of GMP-compliant Site Change
  • 29.-30.09.2021
    Live Online Training: Drug Master File Procedures in the EU, the US and Japan
  • 06.-07.10.2021
    Live Online Training: How to write the Quality Part of an IMPD
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  • 29.10.2020
    Latest Guidances regarding Nitrosamine Impurities
  • 18.05.2020
    Impact of COVID-19 pandemic on Pharma: GMP and Regulatory Flexibility
  • 26.03.2020
    New Deadline for Nitrosamine Impurities
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