Regulatory Affairs | Vaccine Registration 

Ongoing Project of Animal Product Registration

  • Area: Greater St. Louis Area
  • Project Type: Regulatory Affairs

About this Project


Registration of Animal Product


This project is ongoing, PSC Biotech® is helping our client located in St. Louis with registration of their animal product (vaccine) in 3 countries, UK, Australia and New Zealand. This project involved many critical processes such as providing support in terms of building out a regulatory strategy for the registration of the product, developing formats for submission of critical quality, safety and efficacy data and authoring CTD Modules 1-5 for submission to the respective Regulatory agencies as also providing support in post marketing activities and responses to the Regulatory Agencies. The consultants working on this registration project ensured that all the critical information regarding quality, safety and efficacy of the product is covered in the required modules, as well as completing the project within timeline. The client has been very satisfied so far with their registration data being transformed into modular formats, required for submission.

Project Success

This is an ongoing registration project and underway to completion. The client has been very satisified with the data gathered so far.

Related Projects

20 Years & Counting of CQV Services

Commissioning, Qualification, Validation and Engineering services for the clients  facility since its inception.

Cleaning Validation & Decommissioning Project

PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.

Sterile Fill/Finish Laboratory Facilities CQV Project

The operations performed included: Filling, Parts Preparation, Formulation, Filling, Process Support Systems and Cleaning.

How Can We Help You?