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.
This is an ongoing registration project and underway to completion. The client has been very satisified with the data gathered so far.
20 Years & Counting of CQV Services
Cleaning Validation & Decommissioning Project
PSC hired a validation specialist who stayed within budget and the time frame set originally by PSC and the client.