CLINICAL TRIAL MATERIAL (CTM) MANUFACTURING
Executive Overview
The bedrock of drug validation. We offer unwavering support for Pre-Clinical, Phase I, and Phase II studies, ensuring seamless IND, NDA, ANDA and 505-B2 filing. With SmaBio Labs, your clinical journey is both streamlined and fortified.
Clean Room
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Environmentally monitored and qualified room for CTM manufacturing
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Bench top and Walk in Fume Hood
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Biosafety Hood
API and Finished Product Manufacturing
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API and FP Batch Manufacturing for Pre-clinical, Phase 1, Phase 2 studies
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API and FP Packaging and Labeling
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CTM storage and Shipment to Study Sites
Release Testing and Stability Studies
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Test Method Creation
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Phase Appropriate Specifications
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Issuance of COA
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Stability Protocol
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Stability Report
Quality Assurance and Regulatory Support
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Thermal analysis: DSC, TGA
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Polymorph identification and screening: XRPD
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Particle size analysis: Laser diffraction
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Elemental impurity profiling: ICP-MS