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 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.
We pride ourselves on being exceptionally cost-competitive in the US market.
Vici is 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
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