Non-clinical Development

Non-clinical drug development is a complex, regulatory-driven process designed primarily to assess the safety and feasibility of new molecules. Non-clinical testing is done at various phases of drug development, but is of specific importance prior to the start of clinical trials. If it is done well, it can minimize safety risks and maximize your chances of success in the clinical phases.

At HORN Pharmaceutical Consulting, our internal and external specialists help you to make effective and fast drug development decision by providing you with comprehensive services in all areas of non-clinical studies. We provide scientific and regulatory input to your planned non-clinical studies and support you in your development programs (non-clinical pharmacology, pharmacokinetics, pharmacodynamics, toxicology).

We help you to identify the required non-clinical studies for regulatory submissions and ensure that the nonclinical programs support your planned clinical programs. One of the important tasks is also the close interaction with contract laboratories. We evaluate study results and review the detailed non-clinical reports which will finally support your regulatory submission. With our knowledge we ensure that GLP requirements are adequately considered within your development program.

With our in-depth non-clinical knowledge and expertise, you will be able to quickly bring your product into clinical development and to set up the right non-clinical development program. We ensure consistency and reliability of results as outlined by the regulatory Authorities (FDA, EMA, national). Our specialists support you by preparing timely and accurate data for the submission to regulatory Authorities.

Services

In the area of non-clinical studies, we are offering the following customized services:
  • Provision of strategic advice and development of strategies from concept to commercialization of drug product
  • Review of non-clinical documents
  • Interaction with contract laboratories
  • Preparation and organization of meetings with regulatory Authorities
  • Efficient preparation of meeting packages (FDA, EMA, national)
  • Support and advice on study design, study protocols and study reports
  • Conduct of Good Laboratory Practice (GLP) audits
  • Preparation of potential regulatory agency inspections (GLP)
  • Review of proposed product information and drug labelling

HOTLINE

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

Events

  • 29.08.2019
    Frankfurt: Prozessvalidierung - Aktuelle Anforderungen für CMC
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  • 17.-18.09.2019
    Copenhagen: Drug Master File Procedures in the EU, the US and Japan
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  • 27.09.2019
    Frankfurt: Regulatorische Anforderungen an Primärpackmittel
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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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