GLP

Implementing Good Laboratory Practice (GLP) system is always an intellectual and labouring task which requires a great amount of effort. To ease the burden of your organization, HORN Pharmaceutical Consulting provides a comprehensive set of GLP services which ensure the consistency and reliability of results as outlined by the regulatory Authorities (FDA, EMA, national).With us you will quickly bring your product into clinical development and set up the right non-clinical development program.

Our internal and external specialists will help you make effective and fast drug development decision by giving you competent advice in all areas of GLP. Being able to look into a company from an inspector’s point of view, we can offer you customized services for preparation of inspections, planning and installing GLP-compliant Quality Assurance (QA) systems, reviewing and optimizing your individual system as well as planning and conducting of mock-inspections.

Furthermore, we provide scientific and regulatory input to your planned non-clinical studies and support you in your development programs (nonclinical pharmacology, pharmacokinetics, pharmacodynamics, toxicology). We will tell you which studies to perform under GLP. From our GLP professionals, you will receive a comprehensive evaluation and detailed review of your preclinical study results and 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.

Services

We are offering the following customized services in the area of GLP:
  • Development of strategies
  • Support and advice on study design, study protocols and study reports
  • Review of non-clinical documents
  • Interaction with contract laboratories
  • Analytical and laboratory compliance programs
  • Inspection of facilities and processes
  • Audit of final reports.
  • GLP training 
  • Development of Standard Operating Procedures (SOPs)
  • Planning and installation of GLP-compliant QA systems
  • Critical review and optimization of QA systems
  • Preparation of corrective action plans
  • Development of qualification and validation strategies
  • Preparation and review of GLP-agreements
  • Conduct of Good Laboratory Practice (GLP) audits
  • Preparation for potential regulatory agency inspections (GLP)
  • Review of contracts
  • Compliance checks

HOTLINE

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

Events

  • 29.-30.10.2019
    Hamburg: How to provide process validation data in regulatory submission
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  • 13.-14.11.2019
    Mannheim: Projektmanagement in Regulatory Affairs
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  • 19.11.2019
    Brugg: MEGRA StartUp
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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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