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.

Services Offered:

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

Risk Management Plans written
Clinical/Nonclinical Overviews written
PL Readability User Tests performed

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Nov 04, 2021

Regulatory Affairs Outsourcing Considerations

The pharmaceutical market is rapidly evolving and changing. Many pharmaceutical companies are…

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Jan 11, 2022

Marketing Authorization Transfer Considerations

Overview The high level of Mergers and Acquisitions (M&A) reflects the incredibly…

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Apr 26, 2021

Clinical Safety Management Plan and its Importance

The Safety Management Plan (SMP) is one of the most important documents…