Neurvati Neurosciences
Neurvati Neurosciences is a neuroscience-focused company dedicated to advancing drugs that can improve the health and lives of people with neurological and psychiatric disorders. Backed by Blackstone Life Sciences, the company employs a search-evaluate-invest-develop strategy to develop novel therapies, assess neuroscience research, review data, understand regulatory needs, and confirm commercial potential. They collaborate with strategic partners and patient communities to deliver transformative drugs.
Industries
Nr. of Employees
small (1-50)
Products
Radiprodil (investigational therapeutic)
Investigational small-molecule therapeutic candidate developed for treatment of GRIN-related neurodevelopmental disorders and other epilepsy indications; subject to clinical trials and regulatory designation activity.
Radiprodil (investigational therapeutic)
Investigational small-molecule therapeutic candidate developed for treatment of GRIN-related neurodevelopmental disorders and other epilepsy indications; subject to clinical trials and regulatory designation activity.
Services
Clinical development operations
Planning and execution of clinical studies including site monitoring, operational oversight, data management, and GCP process improvements.
Regulatory strategy and submissions
Development of regulatory filing strategies and support for global registrations and regulatory designations.
Business development and partnerships
Evaluation and negotiation of collaborations, licensing, and commercialization partnerships; structuring of deal terms and strategic alliances.
Vendor management and outsourcing oversight
Governance and management of external vendors and CROs to execute development programs.
Patient engagement and community outreach
Integration of patient advocacy perspectives and community engagement into program planning and communications.
Subsidiary formation and program structuring
Creation of dedicated subsidiary entities and tailored corporate structures to advance specific therapeutic programs.
Clinical development operations
Planning and execution of clinical studies including site monitoring, operational oversight, data management, and GCP process improvements.
Regulatory strategy and submissions
Development of regulatory filing strategies and support for global registrations and regulatory designations.
Business development and partnerships
Evaluation and negotiation of collaborations, licensing, and commercialization partnerships; structuring of deal terms and strategic alliances.
Vendor management and outsourcing oversight
Governance and management of external vendors and CROs to execute development programs.
Patient engagement and community outreach
Integration of patient advocacy perspectives and community engagement into program planning and communications.
Subsidiary formation and program structuring
Creation of dedicated subsidiary entities and tailored corporate structures to advance specific therapeutic programs.
Expertise Areas
- Neuroscience drug development
- Clinical development operations
- Regulatory strategy and submissions (FDA/EMA)
- Rare disease and pediatric therapeutics
Key Technologies
- Clinical trial management
- Clinical data management systems
- Medical writing for regulatory submissions
- Regulatory pathway planning (orphan/PRIME/breakthrough)