Confidence Beyond Compliance

EC Directive 2001/20/EC, the Clinical Trials Directive, requires the implementation of Good Clinical Practice (GCP) in the conduct of clinical trials of medicines for human use in the EU and the preparation of the IMP Dossier to be submitted to the Competent Authority for approval of the clinical trial, and also to be submitted to the Ethics Committee for approval.

As per the Directive, the manufacturer of IMPs must hold a Manufacture and Importation Authorization (MIA) and manufacture, test, and release the clinical materials in compliance with GMP, to ensure the quality of the materials used in the clinical trials. Compliance with Annex 13 of the EU Volume 4 GMP Guide on Investigational Medicinal Products, which also includes requirements for the shipping of IMPs, is required.

PharmaLex’s team of experts, which includes a number of former EU regulators, provide expert support through all phases of the clinical program in compliance with GCP, and also provide support in the manufacture and distribution of the IMPs.

These support services include:

  • Assessing and qualifying contract manufacturers of IMPs by means of GMP audits which take a phased approach in relation to the validation of the process and development of specifications for the IMP
  • Assessing and qualifying IMP packaging, labelling and coding contractors by means of GMP audits
  • Developing Quality Technical Agreements with the IMP manufacturer, or other contractors or partners, on behalf of the client as Contract Giver
  • Providing;
    • management and/or oversight of IMP manufacturing, packaging & labelling, coding and QP release operations in accordance with GCP and GMP
    • QP release services, provided by the PharmaLex Ireland QP, for certifying IMPs for release to the Investigator sites, whether manufactured within the EU or manufactured in a third country and imported into the EU (under the MIA)
    • management and/or oversight of the shipment, storage and distribution of IMPs to Investigator sites in accordance with EU GDP and applicable in-country regulations, i.e. ensuring the quality and integrity of the IMP Supply Chain
    • management and/or oversight of the handling and control of IMP inventories by the distributor and at Investigator sites
  • Preparation of the IMP Dossier which includes
    • information on the Investigational Medicinal Product
    • summaries of information related to the quality, manufacture and control of the Investigational Medicinal Product
    • summaries of non-clinical pharmacology and toxicology data for the IMP
    • critical analyses of the available data in relation to the potential risks and benefits of the proposed study