Monitoring of GLP studies (other than residues)

Monitoring of GLP studies (other than residues) logo

The studies are essential for the approval of an active substance and / or product.

These studies must now be conducted according to Good Laboratory Practice (GLP). This will be done internally if your company has GLP and technical resources, but most often externally in a Contract Research Organisation (CRO).

Prior auditing of laboratories and rigorous monitoring of studies are both necessary for their successful implementation: discussion about the concept and associated costs, verification of the study plan and its compliance with the appropriate guideline (EC, OECD , EPPO, EPA), contacts with the Study Director, follow-up of the results and verification of the successive versions of the report until the final report is published.

Staphyt Regulatory team has a long experience in monitoring and auditing all types of studies. Our team has already inspected most of the European and several American contract laboratories.

We offer our experience and support to monitor all kind of studies for a registration dossier: physico-chemistry, analytic methods, toxicology, environmental fate and ecotoxicology.

You need to

  • Identify which studies are missing in your dossier (Data Gap Analysis),
  • Find the appropriate laboratory to conduct the study program in whole or in part,
  • Build a realistic schedule and date of submission, depending on the completion of this program,
  • Ensure that all these studies will be acceptable to the authorities.

Our expertise

  • Identify which studies are needed,
  • Advise you in the selection of the GLP laboratory under contract,
  • Conduct a preliminary audit of the laboratory, within your company if you wish to check in particular: the organization, the technical capacities, the experience and the training of the employees, the archiving, etc…,
  • Discuss, with your agreement, the guideline, study plan, time and cost with the laboratory,
  • Maintain close contact with the Study Director so that there is no delay and an immediate response to any problems during the study,
  • Conduct a study audit, if this study is very critical in the development of your product. The minimum this audit will  include:
    • the control of the study plan and that amendments have been scrupulously followed and that each deviation has been well reported,
    • The verification of all raw data and calculations, particularly for the application phase,
    • The identification of any events that could invalidate the study or modify its conclusions.
  • Audit draft reports until the final report is completed and meets your standards. For each report, our experts will in particular:
    • check the format, according to your requirements and those of the authorities,
    • verify all calculations, data and internal references,
    • ensure that the presentation of the study leads naturally to the conclusion and that the report is easy reading for the evaluator.