GCP

Throughout your product development it is essential to consider various GXP-requirements. You will start with GLP (Good Laboratory Practice) in preclinical phases and will then move to GCP (Good Clinical Practice) for your clinical studies. In addition, you should comply with regulatory requirements and ensure consistency between internal data and regulatory documents (regulatory compliance).

Good Clinical Practice (GCP) procedures entail the obligations of investigators, sponsors, and monitors and their staff in the conduct and legal aspects of clinical research in the process of new product development. Inspections by Authorities and audits by customers become more and more important. As it is of initial interest for a pharmaceutical company to pass all inspections successfully, the preparatory activities are of utmost importance for all involved departments.

Being able to look into a company through inspector’s eyes, we can offer you customized services for preparation of inspections, planning and installing GCP-compliant Quality Assurance (QA) systems, reviewing and optimizing your individual system as well as planning and conducting of mock-inspections.

Services

To help you assure the validity of data resulting from all phases of your clinical research, HORN Pharmaceutical Consulting offers the following GCP services:
  • Strategic advice from concept to commercialisation of drug product
  • Clinical drug development: trial design and phases
  • Preparation, review and submission of
    • Clinical Trials Applications (CTAs) and Investigational New Drugs (INDs)
    • Marketing Application Authorisation (MAA) and New Drug Application (NDA)
  • Preparation and review of :
    • Investigator’s brochures
    • Study protocols
    • Study reports
    • IMPD documents
    • CTD documents
  • Development of standard operating procedures (SOPs)
  • Quality assurance audits for clinical trials
  • Quality issues and audit findings in clinical trials
  • Preparation for Authority inspection of clinical trials (FDA, EMA etc.)
  • Preparation and organization of meeting packages with regulatory affairs
  • General and in-house GCP training

     

HOTLINE

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

Events

  • 27. – 28.09.2016
    Berlin: Change Control – New Aspects and Best Practices
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  • 30.09.2016
    Frankfurt: Prozessvalidierung - Update für CMC
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  • 05.10.2016
    Mannheim: Genotoxische Verunreinigungen
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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.