Regulatory Dossier Writing
Our medical writing and regulatory affairs teams prepare documents required to support the applications at all product lifecycle stages. In compliance with applicable regulations and standards, we also ensure that the efficacy, safety and quality of your medicinal product is demonstrated properly.
Should you require a full CTD dossier to build from scratch, a clinical overview for your renewal or Rx to OTC switch application, a Package Leaflet Readability User Testing, or any other part of the Dossier – we have you covered.
Development of Clinical and Nonclinical Overviews/Summaries (Modules 2.4/2.5/2.6/2.7)
Development of Quality Overall Summaries (Module 2.3)
Preparation of Addendums to Clinical Overview
Preparation of Clinical Overviews / Expert Reports to support classification change (Rx to OTC switch)
Development of Summaries of product characteristics (SPCs) and Package Leaflets (PL)
Package Leaflet Readability User Testing (RUT) or Bridging Reports (Module 1.3.4)
Risk Management Plans (1.8.2)
eCTD publishing activities using a fully validated system