Problem Statement
Client: A law firm was working on litigation issues for vaccine products. The client needed an analytical and Quality expert to conduct a regulatory assessment of product-related issues and provide an assessment report, including a deposition.
Expertise And Solutions
The client company hired PJI Biotech to conduct an assessment of product-related issues and provide an assessment report. Our expert reviewed about 1000s of documents which included Data, trends (analytical, stability, and comparability), regulatory submissions, supplements, related FDA communications, related analytical and stability programs, comparability reports, methods, procedures, OOS and manufacturing investigations, related regulations, guidance documents, and multiple depositions. After extensive document review and discussion for several months, an assessment report was developed as requested by the client. The report was reviewed and approved by the client. After a few months, a deposition was also conducted. All the work was conducted to support the client (law firm), as requested by the client.
Results
As a result, the client was able to meet their key objectives related to the litigation.
Feedback
The client firm was very happy with the support provided, dedication, flexibility, and meeting their key objectives. Specific feedback is as follows:
“Dipti Gulati has been a critical and outstanding member of our team, bringing significant expertise, insight, and focus to our project. She has worked fluidly with us to develop a comprehensive strategy to successfully address our key objectives. Dipti is dedicated, thoughtful, and responsive, and it has always been a pleasure to work together.”