cGMP Custom Synthesis
Custom Synthesis to Support GLP Nonclinical and cGMP
Phase II Studies
Vici Health Sciences provides small batch synthesis to support nonclinical toxicology, 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 high quality, excellent customer service, smooth project execution, and intellectual protection (IP). We pride ourselves on being exceptionally cost-competitive in the US market.
We are a CDMO experienced in early-stage formulation development, Phase I and Phase II clinical batch manufacturing, integrating small batch synthesis, and formulation development. Early phase clinical batch manufacturing can lead to considerable cost and time savings.
- Small scale API synthesis (gram quantities)
- Small scale intermediate synthesis (gram quantities)
- DEA Schedule I-V synthesis, analytical and manufacturing license
- DEA import and export 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
We are DEA Schedule I-V licensed for manufacturing and testing Phase I and Phase II clinical trial supplies and DEA Schedule II-V licensed for manufacturing and testing Phase III clinical trial materials.