Regulatory Affairs | Vaccine Registration

Regulatory Affairs | Vaccine Registration

Regulatory Affairs | Vaccine Registration 

Ongoing Project of Animal Product Registration

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

About this Project

OBJECTIVE

Registration of Animal Product

SERVICES

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.

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Regulatory Affairs, Technical Writing | IND Modification for Phase I Clinical Trial

Regulatory Affairs, Technical Writing | IND Modification for Phase I Clinical Trial

IND Modification for Phase I Clinical Trial

IND Clinical Trial Technical Writing in preparation of FDA submission
  • Area: Greater Seattle Area
  • Project Type: Regulatory Affairs, Technical Writing

About this Project

OBJECTIVE

Client received FDA responses to initial Phase I Clinical Trial submission. Client required support in ensuring documents were modified and complete for FDA submission.

SERVICES

PSC® supported a small, start-up biopharmaceutical company with their Investigational New Drug (IND) application. With commentary from the FDA and a short time-line, PSC provided updates and modifications to the IND Phase I Clinical Trial Submission to ensure FDA approval. PSC® also provided Strategies for Optimization of Design of Forms to set the client up for success for future submissions.

PROJECT SUCCESS

PSC® has successfully completed the IND Modification for Phase I Clinical Trial within scope, schedule, and budget, and received outstanding feedback from the client’s Executive Team.

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Regulatory Affairs | Strategy Support Projects

Regulatory Affairs | Strategy Support Projects

CMC Regulatory Affairs Project

Focused on Plasma-Derived Therapies for Rare and Complex Diseases
  • Area: Cambridge, MA
  • Project Type: Regulatory Affairs

About this Project

OBJECTIVE

Client requires on-going Subject Matter Expertise in global Chemistry Manufacturing Controls (CMC) Guidance and Submissions.

SERVICES

PSC® continues to support the Global Regulatory Affairs division for a large biopharmaceutical company, focused on plasma-derived therapies for rare and complex diseases. This company’s headquarters is in Cambridge, MA, but we support locations in the Greater Atlanta region and Greater Los Angeles region. PSC® has been critical in the development, coordination, and implementation of Global CMC Regulatory Strategies for various programs and tasks, PSC® is a key player in receiving approved submissions by the FDA, EMA, NMPA, and other global regulatory agencies in a timely manner for our client.

PROJECT SUCCESS

PSC® has successfully worked here on various Regulatory Affairs projects and has continuously had projects approved with global regulatory agencies.

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