Pharmaceuticals

The pharmaceutical industry is subject to a variety of laws and regulations regarding the patenting, testing and marketing of drugs. It is essential that all pharmaceutical products are safe, effective, and of good quality.

At HORN Pharmaceutical Consulting we can help you cope with your most complex and specialized challenges. We will develop strategic and operational plans, and improve the efficiency of your internal operations. Our consultants have spent years working in the pharmaceutical industry and providing consulting services to industry clients. We consistently deliver excellent results and create lasting values for our clients.

HORN Pharmaceutical consultants will hep you carry out both large and small projects in all stages of drug development, from initial launch through product maturity. We are experts in all aspects of pharmaceutical production, quality control and quality assurance. We understand your needs; find creative solution for your manufacturing strategies and for your supply chain management. We can support you in your projects with different parties involved across sites, e.g. contract manufacturers, contract laboratories and packaging sites. We will ensure that your projects are managed properly across sites, meeting your project goals as planned.

Furthermore we support you on new product development, line-extensions, commercial strategy development, pharmaceutical product launch, and many other aspects of maximizing the value of pharmaceutical assets. In addition, we know the specific differences in EU and US and can assist you with the design of regulatory strategies and programs in a number of geographic markets.

Services

The following outlines our services offerings:

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
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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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