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