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.
Company Details
- Founded
- -
- Address
- Paris Area, Fr
- Industry
- Biotechnology Research
- NAICS
-
Research and Development in Biotechnology (except Nanobiotechnology)
- Keywords
- Cell therapy, gene therapy, EU and US regulation, Pharmaceutical development, Rare diseases, Immunology, Immunotherapy, Oncology, Tissue Engineered Products, CGT, ATMPs.
- HQ
- PARIS Area
Raising Gene Consulting Questions
Raising Gene Consulting's website is https://www.canva.com/design/DAGQocJb8uA/CIKvtg5dQnT-P2QPxzqeAg/view
Raising Gene Consulting's LinkedIn profile is https://fr.linkedin.com/company/raising-gene-consulting
Raising Gene Consulting's industry is
Biotechnology Research
Raising Gene Consulting's top competitors are
Bioconsult4.0,
Bespark*bio,
Tirigenera,
Bip Partners,
Zedgene,
Aspida,
Nuova Genetica Italiana S.r.l.,
Sangamo Therapeutics France,
Theravectys,
Brainvectis.
Raising Gene Consulting's categories are Biotechnology Research
Raising Gene Consulting's founding year is 2021
