HORN Pharmaceutical Consulting – Quality that matters!

HORN Pharmaceutical Consulting provides regulatory and business advice to companies from the pharmaceutical, biotechnology and medical device industries. We offer a full spectrum of global consulting services and solutions from early phases of product development and clinical trials to submission of marketing authorization applications.


Who we are 

Our internationally experienced specialists have detailed know-how in the planning and preparation of dossiers, e.g. European ASMF (Active Substance Master File), US-DMF (Drug Master File), certificate of suitability (CEP). We prepare regulatory documents for your global submission. For the start of the clinical trial the CTA (Clinical Trial Application) needs to be submitted in EU, and the IND (Investigational New Drug Application) needs to be submitted in US. These are the documents which we will be elaborated with you and will be written for you.

Once you have successfully gone through clinical trials we support you in the preparation of the CTD (Common Technical Document) for submission of the European MAA (Marketing Authorization Application) and the US NDA (New Drug Application) / BLA (Biologic License Application).

Regulatory submissions entail a large variety of documents. We are here to advice you on how to structure and write these documents, and we are prepared to take up this task for you, e.g. SPCs (Summary of Product Characteristics), clinical or nonclinical study protocols and reports, clinical or non-clinical summaries and overviews, Quality Overall Summaries (QOS) as well as CMC documents.

We guide your project through the regulatory process, elaborate regulatory strategies for European and US-filings, and help you in the preparation of meetings with Authorities (national agencies, EMA, FDA).

However, a successful submission also depends on compliance with GMPGCP and GLP standards. We check your compliance status during mock inspections. We help you to ensure adherence to EU and US-requirements and support you in setting up adequate quality systems by writing SOPs and performing training for your personnel.

Whether you are a pharmaceutical or biotechnology company, an API (Active Pharmaceutical Ingredient) manufacturer, contract manufacturer, contract laboratory, SME (Small and Medium-sized Enterprise), medical device industry, Advanced Therapy Industry (ATI), we will help you carry out both large and small projects in all stages of the product lifecycle: in the pre-submission, submission, pre-approval, approval and post-approval phase.

HOTLINE

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

Events

  • 05.10.2016
    Mannheim: Genotoxische Verunreinigungen
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  • 06. – 07.10.2016
    Frankfurt: Regulatorische Anforderungen an Primärpackmittel
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  • 18. – 19.10.2016
    Vienna: Handling Changes and Variations
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News

  • 26.09.2016
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 06.09.2012
    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.