About this Project

OBJECTIVE

The goal of this project was to facilitate the expansion of our client’s veterinary vaccine in three new countries (the UK, Australia, and New Zealand) by authoring CTD Modules 1-5 for submission to respective regulatory agencies.

SERVICES

PSC Biotech® guided our client, a leader in the animal health industry, through the regulatory strategy for their vaccine’s international expansion by developing formats for submission of critical quality, safety, and efficacy data and authoring CTD Modules 1-5 for submission to the respective regulatory agencies. The consultants working on this registration project ensured that all the critical information regarding supporting data demonstrating that the product can be manufactured and used without adversely affecting animal health, human health, food safety, or the environment were well documented in the required modules, as well as providing support in post-marketing activities and responses to the appropriate regulatory agencies. 

Regulatory Agencies:

• Veterinary Medicines Directorate (VMD)
• Australian Pesticides and Veterinary Medicines Authority 
• Ministry for Primary Industries

CTD Modules

The Common Technical Document (CTD) Modules are organized into five modules. Module 1 is region-specific and covers administrative information and prescribing information. Modules 2, 3, 4, and 5 are intended to be common for all regions. These sections include quality summaries, clinical overviews, quality, and clinical and nonclinical study reports. For more information on Common Technical Documents, refer to our Regulatory Series. 

Project Success

The client has been very satisfied so far with their registration data being transformed into modular formats, required for submission. The project execution involving the Module creation has been completed, currently, the application is underway with the Australian agencies.