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.
