Regulatory Dossiers

The authoring of pharmaceutical regulatory dossiers can make disproportionate demands on staff whose unique specialist expertise is also needed to support other business objectives.

Queen’s House Consulting can relieve that workload, providing experienced technical authoring skills for Quality and Non-Clinical dossiers, while your experts retain ownership of their discovery.

Working with you, Queen’s House Consulting can:

  • Transform raw data, intermediate and final reports into clear, concise, English narrative and technical text;
  • Help you formulate the critical questions for scientific advice meetings with regulatory authorities and write the required pre-read materials;
  • Author the investigational medical product dossier section of CTA/IND clinical trial applications;
  • Prepare Modules 2 (quality and non-clinical), 3, and 4 of the Common Technical Dossier for marketing authorisation licence applications.

Please contact Queen’s House Consulting to discuss your specific requirements.

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