Red Rock Regulatory Consultants, LLC

Red Rock Regulatory Consultants, LLC provides consulting services customized to address regulatory strategy and other regulatory filing needs specializing in chemistry, manufacturing and control of biological products, including drug-device combination products, therapeutic proteins, regenerative medicines, and biosimilars. Services include: > Regulatory CMC strategy refinement​ (U.S., EU, Canada and Japan) > FDA meeting preparation > EU scientific advice briefing packages > BLA/MAA risk assessment > CMC regulatory risk assessment > Review of clinical trial applications ​ > Submission project management > Risk-based strategy for product development ​ > Submission authoring ​ > Pre-license inspection readiness > Regulatory intelligence research ​ > Due diligence