Project Evaluation and Selection Criteria

The Product Quality Research Institute (PQRI) is looking for science-based research projects which it may take on to help reduce regulatory burden and improve both the brand and generic sides of drug development. If you would like to submit such a request for research, below please find the procedural steps to approval.

While we cannot guarantee that your submission will be accepted for future work, it will be reviewed and considered by the appropriate Technical Committee and/or Working Group. Once it is agreed that the project may be a viable area of study, you will be notified and additional information in the form of a formal proposal/work plan will be requested.

The submission process is as follows:

• Complete the form below and submit to the PQRI office for consideration.

The review and approval process is as follows:

• The suggestion will be forwarded to the appropriate Technical Committee (TC) for review and consideration.
• Upon acceptance at the Technical Committee level, the proposed work will be forwarded to the Steering Committee (SC) for review and discussion.
• If viewed as a viable area of study, additional information will be sought and a formal proposal and/or work plan will be requested.
• After receipt of the requested information/documents, there will be an additional round of approvals by both the TC and SC.
• If the proposed project passes to this level of approval, the submitter will be requested to present his/her project to the TC/SC.
• If a final approval is then given, a Working Group (WG) will be populated and work begun.

We encourage you to offer additional details relative to the proposed project, however, the below items must be addressed:

1. What is the FDA guidance or issue being addressed?
2. Does it apply to a compendia issue?
3. What scientific evidence is currently available to support your hypothesis?
4. Can PQRI add value by addressing the issue?
5. Is there any other organization that is addressing, or planning to address this topic?
6. Would PQRI finance the project?