Regulatory response letters
Question-and-response exchanges between a sponsor and a regulator during a submission, redacted for product and proprietary data.
- Domain
- Pharma regulatory
- Format
- A regulator's query and the sponsor's response, 500 to 6,000 words, redacted
- Rate
- $110 to $160 per accepted file
- Window
- Opened 19 August 2026 · Closes 27 November 2026
- Attestation
- Required on every file
- Agreement
- Firm or institutional agreement
The call
During review, a regulator asks and the sponsor answers. The exchange is a record of what a regulator finds insufficient and how an experienced regulatory affairs team argues its case. We are acquiring these exchanges with product names, proprietary data and commercially sensitive figures redacted.
The regulatory framework and the therapeutic area should be stated. The exchange should be complete: query, response, and outcome where known.
What qualifies
- Exchanges from completed submissions, any major regulator
- Redacted for product identity and proprietary data
- Contributed under a sponsor or consultancy agreement
What is excluded
- Exchanges from submissions still under review
- Any file with unredacted proprietary data
- Exchanges relating to safety signals under investigation
De-identification
Product, molecule and sponsor names replaced. Proprietary figures redacted. Regulator and framework may stay.
Review
Read by a regulatory affairs professional with submission experience in the relevant framework.
Rights
Full license transferred to Gridfile at acceptance. Sponsor or consultancy agreement required.
GF-0103 · Reviewed by a former regulatory affairs lead