Vici Health Sciences provides small batch synthesis services to support nonclinical toxicology or proof of concept and early phase human clinical studies. Being US-based and cGMP capable, our services are well suited for smaller companies looking for intellectual (IP) protection, high quality, great customer service, and smooth project execution. We are very cost competitive in the US market.
As a CDMO experienced in early-stage formulation development and Phase 1 and Phase 2 clinical batch manufacturing, integrating small batch synthesis, formulation development, and early phase clinical batch manufacturing leads to considerable cost and time savings.
- Small scale API synthesis (gram quantities)
- Small scale intermediate synthesis (gram quantities)
- DEA schedule 1-5 synthesis, analytical and manufacturing license
- DEA export and import license to support international nonclinical toxicology and clinical studies
- API stability studies
- Analytical method development and testing
- Certificate of analysis (COA) provided
- GLP compliant
- Regulatory filing documentation including pre-IND briefing and IND sections authoring
- Vertical integration with formulation development and clinical batch manufacturing
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