Raising Gene Consulting

EU & US - Regulatory definition of the product to list regulatory texts applicable - Identification and scheduling of mandatory, optional, and interesting regulatory procedures - Regulatory roadmap from preclinical to FIH and beyond - High level nonclinical development plan or gap analysis - Ad hoc CMC recommendations based on regulatory texts, other documents and experience - Assistance to write questions and rationales for scientific advice/pre-IND briefing documents- Presentation/explanation of key regulatory procedures - Mid-term or long-term weekly or monthly assistance as regulatory project team member Please feel free to reach out for more information at eferries@raising-gene.com.