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.
Development of regulatory strategies, preparation of meetings with Authorities in EU and US, submission of dossiers [more]
Preparation and review of CMC-documents: IMPD/IND, CTD for MAA/NDA [more]
Project planning, guidance and advice for project teams [more]
Services around GMP/GCP/GLP, development of SOPs, compliance checks [more]
Clinical strategies, clinical documents, e.g IB, study protocol, study report, clinical overviews and summaries [more]
Review of product development status, evaluation of development strategies, preparation of due diligence reports [more]
Training for Regulatory Affairs, GMP, GCP, GLP; in-house training specifically tailored to your needs [more]
Regulatory intelligence focuses on the essentials in the regulatory world [more]
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
for your global submission. For the start of the clinical trial the
(Clinical Trial Application) needs to be submitted in EU, and the
(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
(Marketing Authorization Application) and the US
(New Drug Application) /
(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),
study protocols and reports, clinical or non-clinical summaries and overviews, Quality Overall Summaries (
) as well as
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
standards. We check your compliance status during
. 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
(Active Pharmaceutical Ingredient) manufacturer, contract manufacturer, contract laboratory,
(Small and Medium-sized Enterprise), medical device industry,
Advanced Therapy Industry
(ATI), we will help you carry out both large and small
in all stages of the product lifecycle: in the pre-submission, submission, pre-approval, approval and post-approval phase.
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HORN Pharmaceutical Consulting
CMC – GMP – Regulatory Affairs
Dr. Hiltrud Horn
Am Alten Schloß 1
Phone: +49 (0) 7251/305 527
Fax: +49 (0) 7251/305 528
Mobile: +49 (0) 160/5834 213
© 2016 Horn Pharmaceutical Consulting, produced by
+49 (0) 7251/305 529
+49 (0) 7251/305 528
20. – 21.09.2016
Prague: API Regulatory Starting Materials
27. – 28.09.2016
Berlin: Change Control – New Aspects and Best Practices
Frankfurt: Prozessvalidierung - Update für CMC
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News for the Industry
News on Change Control/Variations:
EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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