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.

Services

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

HOTLINE

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

Events

  • 26.-27.02.2019
    Mannheim: GMP-gerechter Prozess-Transfer
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  • 19.-20.03.2019
    Prague: How to write the Quality Part of an IMPD
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  • 26.-27.03.2019
    Copenhagen: Handling Changes and Variations
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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
    More
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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