Vici Health Sciences, a Maryland-based CDMO is pleased to introduce cGMP API and API intermediate synthesis services to support phase 1 first-in-human clinical studies and GLP nonclinical studies. This program is built on Vici’s deep expertise in CMC (Chemistry Manufacturing and Controls) ranging from early-phase API and intermediate synthesis through IND enabling cGMP clinical supplies manufacturing, and manufacturing tech transfer and troubleshooting. As a client-focused company R&D organization, Vici also offers regulatory and project management support thus providing one-stop early phase CDMO services to drug development sponsors.
Vici’s comprehensive CDMO services to support early phase drug development include:
- Small-scale API and intermediate synthesis
- DEA schedule 1-5 licensed
- Product design and development strategy
- Formulation patent support for intellectual property creation
- Oral formulation development
- Parenteral formulation development
- Analytical method development
- Analytical method validation
- Analytical testing
- Stability studies
- Technical troubleshooting
- cGMP clinical batch manufacturing
- Regulatory filing documentation including pre-IND briefing and IND sections authoring
- ANDA development and ANDA filing
- FDA correspondences
- GLP nonclinical studies support through investigational product manufacturing and testing
- CMO selection consulting
- Manufacturing technical transfer
- Manufacturing OOS troubleshooting
“We are very excited to offer small scale chemical synthesis capabilities to support our clients who often struggle to find gram quantity cGMP API and intermediates to support their drug development programs” noted Dr Anish Dhanarajan, CEO and Founder of Vici Health Sciences. “Vertically integrating our cGMP API synthesis capabilities with our knowledge of cGMP practices, DEA schedule 1-5 capabilities, formulation development, analytical method validation, and cGMP clinical batch manufacturing services allows us to truly be the one-stop CDMO our small and mid-sized Pharma clients desperately seek”.
To contact our team, please email info@vicihealthsciences.com, or call +1 (410) 379-1500.