[Tammy long]

Reply To: Regulatory release of IMP

Thanks, Ed for your detailed reply. We have IP packaged in EU(CMO) and QP will release the batch followed by our QA. Now , we try to ship the drugs to US. Is there any regulatory approval required? For example, IND approved, IRB approved, or submitted.

CMO’s QP will take the responsibility or accountability or our QA has to hold all responsibility for GMP production and country release.